Manufacturer registered with FDA

Mci Medical Concept Innovation, Inc.

Sunrise, FL, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10057752ManufacturerRepacker / relabeler
Device types listed
4
Brands and models
2,162
510(k) clearances
12019–2019
Markets registered in
514 registrations outside the US
Establishments
1United States
2019: 120102020

510(k) clearances per year, 2007–2026

Registered in 5 markets

Where regulators' registries name Mci Medical Concept Innovation, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 4 device types listedBrazil: 7 registrationsColombia: 4 registrationsCosta Rica: 2 registrationsPeru: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerMci Medical Concept Innovation, Inc.1 clearances2019–2019Below
BrazilANVISAManufacturerMCI MEDICAL CONCEPT INNOVATION INC.72020–2025Pure Global AI
ColombiaINVIMARegistration holderMCI MEDICAL CONCEPT INNOVATION INC4—Pure Global AI
Costa RicaMinisterio de SaludManufacturerMCI MEDICAL CONCEPT INNOVATION INC.2—Pure Global AI
PeruDIGEMIDManufacturerMCI MEDICAL CONCEPT INNOVATION INC.12023–2023Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Mci Medical Concept Innovation, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraosseous Fixation ScrewDZL · Class 2Maxillofacial plates & screwsMaker
A011.1000 STRAIGHT MICRO PLATE 4HA011.1002 STRAIGHT MICRO PLATE 6HA011.1004 STRAIGHT MICRO PLATE 8HA011.1006 STRAIGHT MICRO PLATE 10HA011.1012 STRAIGHT MICRO PLATE 16HA011.1017 L MICRO PLATE BRIDGE 6MM 4H RIGHTA011.1018 L MICRO PLATE BRIDGE 6MM 4H LEFTA011.1019 L MICRO PLATE BRIDGE 8MM 4H RIGHTA011.1020 L MICRO PLATE BRIDGE 8MM 4H LEFTA011.1021 L MICRO PLATE BRIDGE 10MM 4H RIGHT
1,055 more
A011.1022 L MICRO PLATE BRIDGE 10MM 4H LEFTA011.1043 L MICRO PLATE OBLIQUE BRIDGE 8MM 4H RIGHTA011.1044 L MICRO PLATE OBLIQUE BRIDGE 8MM 4H LEFTA011.1051 L MICRO PLATE OBLIQUE BRIDGE 8MM 5H RIGHTA011.1052 L MICRO PLATE OBLIQUE BRIDGE 8MM 5H LEFTA011.1089 LEFORT MICRO PLATE 11H # 0.6MM LEFTA011.1090 LEFORT MICRO PLATE 11H # 0.6MM RIGHTA011.1091 LEFORT MICRO PLATE 11H OFFSET 2MM # 0.6MM LEFTA011.1092 LEFORT MICRO PLATE 11H OFFSET 2MM # 0.6MM RIGHTA011.1095 LEFORT MICRO PLATE 11H OFFSET 4MM # 0.6MM LEFTA011.1096 LEFORT MICRO PLATE 11H OFFSET 4MM # 0.6MM RIGHTA011.1099 LEFORT MICRO PLATE 11H OFFSET 6MM # 0.6MM LEFTA011.1100 LEFORT MICRO PLATE 11H OFFSET 6MM # 0.6MM RIGHTA011.1103 LEFORT MICRO PLATE 11H OFFSET 8MM # 0.6MM LEFTA011.1104 LEFORT MICRO PLATE 11H OFFSET 8MM # 0.6MM RIGHTA011.1137 ANGLED MICRO PLATE FOR PIRIFORMIS # 0.6MM RIGHTA011.1138 ANGLED MICRO PLATE FOR PIRIFORMIS # 0.6MM LEFTA011.1139 2MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1140 2MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1143 4MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1144 4MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1145 6MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1146 6MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1147 8MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1148 8MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1149 10MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1150 10MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1153 12MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1154 12MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1248 ORBITAL MICRO PLATE 8HA011.1249 ORBITAL MICRO PLATE 10HA011.1266 STRAIGHT MICRO PLATE 20HA011.1267 STRAIGHT MICRO PLATE BRIDGE 6MM X 4HA011.1269 STRAIGHT MICRO PLATE BRIDGE 10MM X 4HA011.1270 STRAIGHT MICRO PLATE BRIDGE 12MM X 4HA011.1271 STRAIGHT MICRO PLATE BRIDGE 6MM X 6HA011.1273 STRAIGHT MICRO PLATE BRIDGE 10MM X 6HA011.1287 T MICRO PLATE BRIDGE 6MM 4HA011.1291 T MICRO PLATE BRIDGE 5H 6MMA011.1292 T MICRO PLATE BRIDGE 8MM 5HA011.1328 X MICRO PLATE BRIDGE 5MMA011.1330 X MICRO PLATE BRIDGE 9MMA011.1335 Y MICRO PLATE BRIDGE 8MM 5HA011.1336 Y MICRO PLATE BRIDGE 10MM 5HA011.1345 SUPPORT ZYGOMATIC MICRO PLATE RIGHTA011.1346 SUPPORT ZYGOMATIC MICRO PLATE LEFTA011.1359 H NASAL MICRO PLATE12HA011.1360 I NASAL MICRO PLATE 11HA011.1361 I NASAL MICRO PLATE 12HA011.1396 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.6 RIGHTA011.1397 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.6LEFTA011.1398 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.6 RIGHTA011.1399 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.6 LEFTA011.1400 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.6 RIGHTA011.1401 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.6 LEFTA011.1402 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.7 RIGHTA011.1403 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.7 LEFTA011.1404 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.7 RIGHTA011.1405 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.7 LEFTA011.1406 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.7 RIGHTA011.1407 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.7 LEFTA011.1408 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.8 RIGHTA011.1409 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.8 LEFTA011.1410 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.8 RIGHTA011.1411 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.8 LEFTA011.1412 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.8 RIGHTA011.1413 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.8 LEFTA011.2000 STRAIGHT MINI PLATE 4HA011.2002 STRAIGHT MINI PLATE 6HA011.2008 STRAIGHT MINI PLATE 12HA011.2012 STRAIGHT MINI PLATE 16HA011.2014 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 10.5MM DFA011.2015 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 13.5MM DFA011.2016 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 16.5MM DFA011.2026 20 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 10.5MM DFA011.2027 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 13.5MM DFA011.2028 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 16.5MM DFA011.2075 L MINI PLATE 4H DFA011.2077 L MINI PLATE 6H DFA011.2101 L MINI PLATE BRIDGE 9MM 4H DFA011.2103 L MINI PLATE BRIDGE 12MM 4H DFA011.2107 L MINI PLATE BRIDGE 18MM 4H DFA011.2155 L MINI PLATE BRIDGE 9MM 6H DFA011.2263 L MINI PLATE OBLIQUE BRIDGE 9MM 6H DFA011.2300 ORBITAL MINI PLATE 6HA011.2301 ORBITAL MINI PLATE 8HA011.2302 ORBITAL MINI PLATE 10HA011.2303 CHIN MINI PLATE 2MMA011.2305 CHIN MINI PLATE 4MMA011.2306 CHIN MINI PLATE 5MMA011.2307 CHIN MINI PLATE 6MMA011.2308 CHIN MINI PLATE 7MMA011.2309 CHIN MINI PLATE 8MMA011.2310 CHIN MINI PLATE 9MMA011.2311 CHIN MINI PLATE 10MMA011.2312 CHIN MINI PLATE 11MMA011.2313 CHIN MINI PLATE 12MMA011.2314 CHIN MINI PLATE 13MMA011.2315 CHIN MINI PLATE 14MMA011.2316 CHIN MINI PLATE 15MMA011.2317 CHIN MINI PLATE 16MMA011.2351 STRAIGHT MINI PLATE 20HA011.2352 SAGITTAL MINI PLATEA011.2354 DOUBLE LINE MINI PLATE BRIDGE 10.5MM 8HA011.2355 DOUBLE LINE MINI PLATE BRIDGE 13.5MM 8HA011.2356 DOUBLE LINE MINI PLATE BRIDGE 16.5MM 8HA011.2360 STRAIGHT MINI PLATE BRIDGE 9MM 4HA011.2363 STRAIGHT MINI PLATE BRIDGE 13.5MM 4HA011.2371 STRAIGHT MINI PLATE BRIDGE 9MM 6HA011.2374 STRAIGHT MINI PLATE BRIDGE 13.5MM 6HA011.2387 T MINI PLATE 4HA011.2389 T MINI PLATE 6HA011.2495 Y MINI PLATE 5HA011.2511 S/Z MINI PLATE 6.5MM DFA011.2512 S/Z MINI PLATE 9MM DFA011.2513 S/Z MINI PLATE 12MM DFA011.2617 T ORBITAL MINI PLATE BRIDGE 9MM 8HA011.2649 STRAIGHT MINI PLATE 6H BRIDGE TABA011.2650 STRAIGHT MINI PLATE 4H BRIDGE 12 MM TABA011.2651 STRAIGHT MINI PLATE 4H BRIDGE 16.5 MM TABA011.2652 STRAIGHT MINI PLATE 4H BRIDGE 21.5 MM TABA011.2653 STRAIGHT MINI PLATE 4H BRIDGE 26.5 MM TABA011.2655 CHIN MINI PLATE OFFSET 2MM TABA011.2656 CHIN MINI PLATE OFFSET 3MM TABA011.2657 CHIN MINI PLATE OFFSET 4MM TABA011.2658 CHIN MINI PLATE OFFSET 5MM TABA011.2659 CHIN MINI PLATE OFFSET 6MM TABA011.2660 CHIN MINI PLATE OFFSET 8MM TABA011.2661 CHIN MINI PLATE OFFSET 10MM TABA011.2662 L MINI PLATE BRIDGE 9MM LEFT TABA011.2663 L MINI PLATE BRIDGE 13.5MM LEFT TABA011.2664 L MINI PLATE BRIDGE 17.5MM LEFT TABA011.2665 L MINI PLATE BRIDGE 21.5MM LEFT TABA011.2666 L MINI PLATE BRIDGE 9MM RIGHT TABA011.2667 L MINI PLATE BRIDGE 13.5MM RIGHT TABA011.2668 L MINI PLATE BRIDGE 17.5MM RIGHT TABA011.2669 L MINI PLATE BRIDGE 21.5MM RIGHT TABA011.2670 L MINI PLATE BRIDGE 12MM DOUBLE RIGHT TABA011.2671 L MINI PLATE BRIDGE 15MM DOUBLE RIGHT TABA011.2672 L MINI PLATE BRIDGE 20MM DOUBLE RIGHT TAB
2019
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
A021.1413 RETRACTOR CHEEK OF TRANSBUCCAL
2018
Operative PliersEJY · Class 1Dental hand instrumentsMaker
A021.3000 LANGENBECK RETRACTORA021.3001 LARGE SERRATED RETRACTORA021.3002 LARGE RETRACTORA021.3003 SMALL SERRATED RETRACTORA021.3004 SMALL RETRACTORA021.3005 REVERSE CURVED V RETRACTORA021.3006 CURVED V RETRACTORA021.3007 THIN MAXILLARY CHISELA021.3008 LARGE MAXILLARY CHISELA021.3009 SMALL MAXILLARY CHISEL
21 more
A021.3010 OCHSENBEIN CHISEL, FORKED TIPSA021.3011 OCHSENBEIN CHISEL, SOLID TIPSA021.3012 V-SHAPED RETRACTORA021.3013 OBWEGESER DOWNWARD RETRACTORA021.3014 REVERSE L-SHAPED RETRACTORA021.3015 LANGENBECK PROXIMAL SEGMENT POSITIONERA021.3016 MODIFIED DOUBLE-ENDED LANGENBECK RETRACTOR, 5 X 18 MMA021.3017 MODIFIED DOUBLE-ENDED LANGENBECK RETRACTOR, 12 X 60 MMA021.3018 MODIFIED DOUBLE-ENDED LANGENBECK RETRACTOR, 10 X 40 MMA021.3019 MODIFIED DOUBLE-ENDED LANGENBECK RETRACTOR, 7 X 25 MMA021.3020 ANGLED LANGENBECK RETRACTORA021.3021 LARGE CURVED RETRACTORA021.3022 SMALL MAXILLARY CHISEL, 5 X 16 MMA021.3023 SMALL MAXILLARY CHISEL, 5 X 20 MMA021.3024 HOOK RETRACTORA021000 PLATE CUTTER 1.5 - 2A021001 MODELING PLIERS 1.5A021002 MODELING PLIERS 2A021003 BENDING PLIERS 1.5 - 2A022004 SMALL SCISSORS CUTTING PLIERSA022007 MESH MODELING PLIERS
2018
Bone PlateJEY · Class 2Maxillofacial plates & screwsMaker
A011.1000 STRAIGHT MICRO PLATE 4HA011.1002 STRAIGHT MICRO PLATE 6HA011.1004 STRAIGHT MICRO PLATE 8HA011.1006 STRAIGHT MICRO PLATE 10HA011.1012 STRAIGHT MICRO PLATE 16HA011.1017 L MICRO PLATE BRIDGE 6MM 4H RIGHTA011.1018 L MICRO PLATE BRIDGE 6MM 4H LEFTA011.1019 L MICRO PLATE BRIDGE 8MM 4H RIGHTA011.1020 L MICRO PLATE BRIDGE 8MM 4H LEFTA011.1021 L MICRO PLATE BRIDGE 10MM 4H RIGHT
1,055 more
A011.1022 L MICRO PLATE BRIDGE 10MM 4H LEFTA011.1043 L MICRO PLATE OBLIQUE BRIDGE 8MM 4H RIGHTA011.1044 L MICRO PLATE OBLIQUE BRIDGE 8MM 4H LEFTA011.1051 L MICRO PLATE OBLIQUE BRIDGE 8MM 5H RIGHTA011.1052 L MICRO PLATE OBLIQUE BRIDGE 8MM 5H LEFTA011.1089 LEFORT MICRO PLATE 11H # 0.6MM LEFTA011.1090 LEFORT MICRO PLATE 11H # 0.6MM RIGHTA011.1091 LEFORT MICRO PLATE 11H OFFSET 2MM # 0.6MM LEFTA011.1092 LEFORT MICRO PLATE 11H OFFSET 2MM # 0.6MM RIGHTA011.1095 LEFORT MICRO PLATE 11H OFFSET 4MM # 0.6MM LEFTA011.1096 LEFORT MICRO PLATE 11H OFFSET 4MM # 0.6MM RIGHTA011.1099 LEFORT MICRO PLATE 11H OFFSET 6MM # 0.6MM LEFTA011.1100 LEFORT MICRO PLATE 11H OFFSET 6MM # 0.6MM RIGHTA011.1103 LEFORT MICRO PLATE 11H OFFSET 8MM # 0.6MM LEFTA011.1104 LEFORT MICRO PLATE 11H OFFSET 8MM # 0.6MM RIGHTA011.1137 ANGLED MICRO PLATE FOR PIRIFORMIS # 0.6MM RIGHTA011.1138 ANGLED MICRO PLATE FOR PIRIFORMIS # 0.6MM LEFTA011.1139 2MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1140 2MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1143 4MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1144 4MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1145 6MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1146 6MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1147 8MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1148 8MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1149 10MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1150 10MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1153 12MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM RIGHTA011.1154 12MM OFFSET ANGLED PIRIFORMIS MICRO PLATE # 0.6MM LEFTA011.1248 ORBITAL MICRO PLATE 8HA011.1249 ORBITAL MICRO PLATE 10HA011.1266 STRAIGHT MICRO PLATE 20HA011.1267 STRAIGHT MICRO PLATE BRIDGE 6MM X 4HA011.1269 STRAIGHT MICRO PLATE BRIDGE 10MM X 4HA011.1270 STRAIGHT MICRO PLATE BRIDGE 12MM X 4HA011.1271 STRAIGHT MICRO PLATE BRIDGE 6MM X 6HA011.1273 STRAIGHT MICRO PLATE BRIDGE 10MM X 6HA011.1287 T MICRO PLATE BRIDGE 6MM 4HA011.1291 T MICRO PLATE BRIDGE 5H 6MMA011.1292 T MICRO PLATE BRIDGE 8MM 5HA011.1328 X MICRO PLATE BRIDGE 5MMA011.1330 X MICRO PLATE BRIDGE 9MMA011.1335 Y MICRO PLATE BRIDGE 8MM 5HA011.1336 Y MICRO PLATE BRIDGE 10MM 5HA011.1345 SUPPORT ZYGOMATIC MICRO PLATE RIGHTA011.1346 SUPPORT ZYGOMATIC MICRO PLATE LEFTA011.1359 H NASAL MICRO PLATE12HA011.1360 I NASAL MICRO PLATE 11HA011.1361 I NASAL MICRO PLATE 12HA011.1396 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.6 RIGHTA011.1397 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.6LEFTA011.1398 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.6 RIGHTA011.1399 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.6 LEFTA011.1400 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.6 RIGHTA011.1401 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.6 LEFTA011.1402 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.7 RIGHTA011.1403 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.7 LEFTA011.1404 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.7 RIGHTA011.1405 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.7 LEFTA011.1406 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.7 RIGHTA011.1407 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.7 LEFTA011.1408 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.8 RIGHTA011.1409 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.8 LEFTA011.1410 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.8 RIGHTA011.1411 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 14MM #0.8 LEFTA011.1412 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.8 RIGHTA011.1413 L OBLIQUE ORBITAL MICRO PLATE BRIDGE 18MM #0.8 LEFTA011.2000 STRAIGHT MINI PLATE 4HA011.2002 STRAIGHT MINI PLATE 6HA011.2008 STRAIGHT MINI PLATE 12HA011.2012 STRAIGHT MINI PLATE 16HA011.2014 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 10.5MM DFA011.2015 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 13.5MM DFA011.2016 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 16.5MM DFA011.2026 20 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 10.5MM DFA011.2027 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 13.5MM DFA011.2028 10 ° BSSO DUAL ANGLED MINI PLATE BRIDGE 16.5MM DFA011.2075 L MINI PLATE 4H DFA011.2077 L MINI PLATE 6H DFA011.2101 L MINI PLATE BRIDGE 9MM 4H DFA011.2103 L MINI PLATE BRIDGE 12MM 4H DFA011.2107 L MINI PLATE BRIDGE 18MM 4H DFA011.2155 L MINI PLATE BRIDGE 9MM 6H DFA011.2263 L MINI PLATE OBLIQUE BRIDGE 9MM 6H DFA011.2300 ORBITAL MINI PLATE 6HA011.2301 ORBITAL MINI PLATE 8HA011.2302 ORBITAL MINI PLATE 10HA011.2303 CHIN MINI PLATE 2MMA011.2305 CHIN MINI PLATE 4MMA011.2306 CHIN MINI PLATE 5MMA011.2307 CHIN MINI PLATE 6MMA011.2308 CHIN MINI PLATE 7MMA011.2309 CHIN MINI PLATE 8MMA011.2310 CHIN MINI PLATE 9MMA011.2311 CHIN MINI PLATE 10MMA011.2312 CHIN MINI PLATE 11MMA011.2313 CHIN MINI PLATE 12MMA011.2314 CHIN MINI PLATE 13MMA011.2315 CHIN MINI PLATE 14MMA011.2316 CHIN MINI PLATE 15MMA011.2317 CHIN MINI PLATE 16MMA011.2351 STRAIGHT MINI PLATE 20HA011.2352 SAGITTAL MINI PLATEA011.2354 DOUBLE LINE MINI PLATE BRIDGE 10.5MM 8HA011.2355 DOUBLE LINE MINI PLATE BRIDGE 13.5MM 8HA011.2356 DOUBLE LINE MINI PLATE BRIDGE 16.5MM 8HA011.2360 STRAIGHT MINI PLATE BRIDGE 9MM 4HA011.2363 STRAIGHT MINI PLATE BRIDGE 13.5MM 4HA011.2371 STRAIGHT MINI PLATE BRIDGE 9MM 6HA011.2374 STRAIGHT MINI PLATE BRIDGE 13.5MM 6HA011.2387 T MINI PLATE 4HA011.2389 T MINI PLATE 6HA011.2495 Y MINI PLATE 5HA011.2511 S/Z MINI PLATE 6.5MM DFA011.2512 S/Z MINI PLATE 9MM DFA011.2513 S/Z MINI PLATE 12MM DFA011.2617 T ORBITAL MINI PLATE BRIDGE 9MM 8HA011.2649 STRAIGHT MINI PLATE 6H BRIDGE TABA011.2650 STRAIGHT MINI PLATE 4H BRIDGE 12 MM TABA011.2651 STRAIGHT MINI PLATE 4H BRIDGE 16.5 MM TABA011.2652 STRAIGHT MINI PLATE 4H BRIDGE 21.5 MM TABA011.2653 STRAIGHT MINI PLATE 4H BRIDGE 26.5 MM TABA011.2655 CHIN MINI PLATE OFFSET 2MM TABA011.2656 CHIN MINI PLATE OFFSET 3MM TABA011.2657 CHIN MINI PLATE OFFSET 4MM TABA011.2658 CHIN MINI PLATE OFFSET 5MM TABA011.2659 CHIN MINI PLATE OFFSET 6MM TABA011.2660 CHIN MINI PLATE OFFSET 8MM TABA011.2661 CHIN MINI PLATE OFFSET 10MM TABA011.2662 L MINI PLATE BRIDGE 9MM LEFT TABA011.2663 L MINI PLATE BRIDGE 13.5MM LEFT TABA011.2664 L MINI PLATE BRIDGE 17.5MM LEFT TABA011.2665 L MINI PLATE BRIDGE 21.5MM LEFT TABA011.2666 L MINI PLATE BRIDGE 9MM RIGHT TABA011.2667 L MINI PLATE BRIDGE 13.5MM RIGHT TABA011.2668 L MINI PLATE BRIDGE 17.5MM RIGHT TABA011.2669 L MINI PLATE BRIDGE 21.5MM RIGHT TABA011.2670 L MINI PLATE BRIDGE 12MM DOUBLE RIGHT TABA011.2671 L MINI PLATE BRIDGE 15MM DOUBLE RIGHT TABA011.2672 L MINI PLATE BRIDGE 20MM DOUBLE RIGHT TAB
2019

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Mci Medical Concept Innovation, Inc. as the applicant.

Decided510(k)DeviceDevice type
5 Dec 2019K182758MCI - CMF SystemJEY Bone Plate

Registered establishments

EstablishmentLocationWhat it does
MCI MEDICAL CONCEPT INNOVATION INC.FDA reg. 1000606483Sunrise, FL, United StatesManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10057752). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.