Manufacturer registered with FDA

MicroPort Orthopedics Inc.

Arlington, TN, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10045253Repacker / relabelerSpecification developer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
131,856 registrations outside the US
Establishments
1United States

Registered in 13 markets

Where regulators' registries name MicroPort Orthopedics Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedCanada: 1,058 registrationsColombia: 557 registrationsSouth Korea: 77 registrationsBrazil: 46 registrationsAustralia: 40 registrationsSaudi Arabia: 28 registrationsEgypt: 12 registrationsTaiwan: 12 registrationsChina: 10 registrationsEuropean Union: 7 registrationsPeru: 6 registrationsCosta Rica: 3 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerMicroPort Orthopedics Inc.1 device types—Below
CanadaHealth CanadaRegistration holderMICROPORT ORTHOPEDICS INC.1,0581999–2026Pure Global AI
ColombiaINVIMARegistration holderMICROPORT ORTHOPEDICS INC.MICROPORT ORTHOPEDICS INC · MICROPORT ORTHOPEDICS LTD557—Pure Global AI
South KoreaMFDSManufacturerMicroPort Orthopedics Inc.MicroPort Orthopedics Inc.,772003–2025Pure Global AI
BrazilANVISAManufacturerMICROPORT ORTHOPEDICS INCMICROPORT ORTHOPEDICS INC.462006–2026Pure Global AI
AustraliaTGARegistration holderMicroPort Orthopedics Pty LtdMicroPort Orthopedics Inc402012–2025Pure Global AI
Saudi ArabiaSFDAManufacturerMicroPort Orthopedics Inc.28—Pure Global AI
EgyptEDAManufacturerMicroport Orthopedics Inc.,Microport Orthopedics Inc.,,122024–2026Pure Global AI
TaiwanTFDAManufacturerMICROPORT ORTHOPEDICS INC.121994–2020Pure Global AI
ChinaNMPARegistration holder微创骨科股份有限公司MicroPort Orthopedics, Inc.微创骨科股份有限公司MicroPort Orthopedics Inc. · 微创骨科股份有限公司 MicroPort Orthopedics, Inc. · +210—Pure Global AI
European UnionEUDAMEDManufacturerMicroPort Orthopedics Inc.7—Pure Global AI
PeruDIGEMIDManufacturerMICROPORT ORTHOPEDICS INC62015–2024Pure Global AI
Costa RicaMinisterio de SaludManufacturerMICROPORT ORTHOPEDICS INC.3—Pure 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 MicroPort Orthopedics Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker
Chisel
2014

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

Registered establishments

EstablishmentLocationWhat it does
MICROPORT ORTHOPEDICS INC.FDA reg. 3010536692Arlington, TN, United StatesRepacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10045253). 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.