Not currently registered with FDA under this name
Walter Lorenz Surgical, Inc.
Jacksonville, FL, United States. Named as applicant on 29 dental 510(k) clearances between 1986 and 2007. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 291986–2007
- Markets registered in
- 24 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Walter Lorenz Surgical, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Walter Lorenz Surgical, Inc. | 29 clearances | 1986–2007 | Below |
| South Korea | MFDS | Manufacturer | Walter Lorenz Surgical Inc.Walter Lorenz Surgical. Inc. | 4 | 2001–2002 | 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
510(k) clearances
Clearances on which FDA names Walter Lorenz Surgical, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Feb 2007 | K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | OAT Orthodontic Endosseous Implant |
| 12 Jan 2007 | K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | JEY Bone Plate |
| 8 Nov 2004 | K042516 | OTOMIMIX | NEA Nose and Throat Ear Cement |
| 14 May 2004 | K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | JEY Bone Plate |
| 5 May 2004 | K040983 | LORENZ SELF-DRILLING IMF SCREW | DZE Root-Form Endosseous Implant |
| 17 Jun 2003 | K031696 | LORENZE EXTERNAL MANDIBULAR DISTRACTOR | MQN External Mandibular Fixator and/or Distractor |
| 21 May 2002 | K021522 | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW | DZL Intraosseous Fixation Screw |
| 22 Feb 2002 | K020407 | LORENZ BLUE DEVICE | MQN External Mandibular Fixator and/or Distractor |
| 6 Aug 2001 | K002790 | ADD-ON CONDYLE | NEI Temporary Mandibular Condyle Prosthesis |
| 12 Feb 2001 | K002083 | LORENZ RESORBABLE DISTRACTOR SYSTEM | JEY Bone Plate |
| 3 May 2000 | K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | JEY Bone Plate |
| 19 Nov 1999 | K992952 | LORENZ DISTRACTION SYSTEM | MQN External Mandibular Fixator and/or Distractor |
| 17 Sep 1999 | K992873 | LORENZ EXTERNAL MANDIBULAR DISTRACTOR | MQN External Mandibular Fixator and/or Distractor |
| 13 May 1999 | K983728 | LORENZ IMF SCREW | DZL Intraosseous Fixation Screw |
| 12 Nov 1998 | K982906 | LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM | MQN External Mandibular Fixator and/or Distractor |
| 23 Oct 1998 | K982604 | LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM | MQN External Mandibular Fixator and/or Distractor |
| 11 May 1998 | K980512 | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW | JEY Bone Plate |
| 18 Aug 1997 | K972322 | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES | JEY Bone Plate |
| 28 Sep 1995 | K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM | JEY Bone Plate |
| 23 Dec 1992 | K922741 | LORENZ 1.0 MM SYSTEM | JEY Bone Plate |
| 20 Feb 1991 | K910038 | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM | JEY Bone Plate |
| 5 Sep 1986 | K862532 | DUMBACH TITANIUM MESH IMPLANT SYSTEM | JEY Bone Plate |
| 7 Aug 1986 | K862534 | PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS | JEY Bone Plate |
| 7 Aug 1986 | K862505 | MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM | JEY Bone Plate |
| 1 Aug 1986 | K862533 | MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE | JEY Bone Plate |
| 1 Aug 1986 | K862523 | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS | EKW Endodontic Broach |
| 25 Jul 1986 | K862482 | STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS | JEY Bone Plate |
| 28 Feb 1986 | K854887 | MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT | EMH Surgical Rongeur Forceps |
| 21 Jan 1986 | K854886 | WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: Biomet Microfixation (15), Stryker (1).
Sources
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 of the most recent filing, which can be a US agent.