Manufacturer registered with FDA

Zimmer Inc

Warsaw, IN, United States. Lists 7 dental device types with FDA across 4 registered establishments, and holds 14 510(k) clearances as applicant.

FDA owner/operator1825034FDA owner/operator1822565Contract manufacturerManufacturerRepacker / relabeler

Device types listed: 7
Brands and models: 45
510(k) clearances: 141994–2001
Markets registered in: 7730 registrations outside the US
Establishments: 4China, France, United States

510(k) clearances per year, 1990–2026

Registered in 7 markets

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

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Zimmer Inc	14 clearances	1994–2001	Below
Taiwan	TFDA	Manufacturer	ZIMMER,INC.ZIMMER INC. · ZIMMER, INC. · +2	198	1974–2026	Pure Global AI
Colombia	INVIMA	Manufacturer	ZIMMER INCBIOMET FRANCE SARL · CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD · +2	191	—	Pure Global AI
Brazil	ANVISA	Manufacturer	ZIMMER, INCZIMMER, INC. · BIOMET FRANCE · +2	128	2007–2026	Pure Global AI
Peru	DIGEMID	Manufacturer	ZIMMER INCZIMMER, INC · ZIMMER, INC. · +2	91	2015–2025	Pure Global AI
China	NMPA	Registration holder	美国捷迈公司Zimmer Inc.法国邦美公司Biomet France · 瑞士捷迈公司Zimmer GmbH · +2	73	—	Pure Global AI
Israel	AMAR	Manufacturer	Zimmer, Inc.Biomet France · Zimmer Inc · +2	49	—	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 Zimmer Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Bone PlateJEY · Class 2	Maxillofacial plates & screws	Maker	AND PREBENTBIOMET MICROFIXATIONBiomet Microfixation OmniMax MMF SystemDISTRACTOR SYSTEMFACIAL PLATING SYSTEMFRACTURE/RECONSTRUCTIONLACTOSORB RAPIDFLAPLORENZ 1.5 MMLORENZ 1MM,LORENZ RECONSTRUCTION 19 more LORENZ RESORBABLELORENZ RESORBABLE DISTRACTIONLORENZ TITANIUM FRACTUREMANDIBULAR FRACTUREMINI BONE PLATESNEURO PACKPLATES SYSTEMSRECONSTRUCTION DEVICESRECONSTRUCTION PLATING SYSTEMSYSTEM (TRAUMAONE)SYSTEM OR EXPANDERSYSTEM WITH MODULAR SCREWTITANIUMWUERZBURGWUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS/LORENZ 2 FT PLATES& BONE SCREWS1.5MM, 2MM SYSTEM20-HOLE ADAPTATION PLATE	2008
Intraosseous Fixation ScrewDZL · Class 2	Maxillofacial plates & screws	Maker	Biomet Microfixation OmniMax MMF SystemJUGGERKNOT MINI SOFT ANCHORLACTOSORB PUSH SCREWLORENZ IMF SCREWMEMBRANE TACK2.5 MM LACTOSORB SCREWS	2008
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	IMF SCREWLORENZSELF-DRILLING	2014
External Mandibular Fixator and/or DistractorMQN · Class 2	Maxillofacial plates & screws	Maker	LORENZ BLUE DEVICELORENZ DISTRACTIONSYSTEM	2014
Dental Fiber Optic LightEAY · Class 1	Dental operating lights	Maker	LIGHT CABLE	2002
Synthetic Bone Grafting MaterialLYC · Class 2	Bone grafts & membranes	Maker	ENDOBON XENOGRAFT GRANULES	2013
Temporary Mandibular Condyle ProsthesisNEI · Class 2	—	Maker	ADD-ON CONDYLETRAUMAONE SYSTEM	2014

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 Zimmer Inc as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
7 Aug 2001	K003281	LACTOSORB RAPIDFLAP	JEY Bone Plate
9 Apr 2001	K003494	MIMIX BONE REPLACEMENT SYSTEM	LYC Synthetic Bone Grafting Material
9 Feb 2001	K003493	3I CALCIUM SODIUM PHOSPHATE BONE CEMENT	LYC Synthetic Bone Grafting Material
20 Oct 2000	K002423	LACTOSORB PUSH SCREW	DZL Intraosseous Fixation Screw
20 Aug 1999	K992158	LACTOSORB SHEETS	JEY Bone Plate
3 Nov 1998	K981666	2.5 MM LACTOSORB SCREWS	DZL Intraosseous Fixation Screw
14 Jul 1998	K981459	MEMBRANE TACK	DZL Intraosseous Fixation Screw
5 Jun 1998	K980927	LACTOSORB PANELS AND FASTENERS	JEY Bone Plate
20 May 1998	K981070	20-HOLE ADAPTATION PLATE	JEY Bone Plate
3 Apr 1998	K980679	ENDOBON	LYC Synthetic Bone Grafting Material
14 Feb 1996	K955640	LORENZ MANDIBULAR DISTRACTOR	MQN External Mandibular Fixator and/or Distractor
29 Sep 1994	K941621	LORENZ SURGICAL FINNED DENTAL IMPLANT	DZE Root-Form Endosseous Implant
29 Sep 1994	K941620	LORENZ SURGICAL CYLINDER DENTAL IMPLANT	DZE Root-Form Endosseous Implant
29 Sep 1994	K941619	LORENZ SURGICAL THREADED DENTAL IMPLANT	DZE Root-Form Endosseous Implant

Also lists devices cleared under other names

Zimmer Inc lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Biomet Sports Medicine (1).

Decided	510(k)	Device	Applicant	Device type
2 Oct 2014	K140908	JUGGERKNOT MINI SOFT ANCHOR	Biomet Sports Medicine	DZL Intraosseous Fixation Screw

Registered establishments

Establishment	Location	What it does
BIOMET FRANCEFDA reg. 3006946279	Valence Drome, France	Contract manufacturer
BIOMET, INC.FDA reg. 1825034	WARSAW, IN, United States	Contract manufacturer, Manufacturer
Changzhou Biomet Medical Devices Co., Ltd.FDA reg. 3007923096	Changzhou City Jiangsu, China	Contract manufacturer
ZIMMER, INC.FDA reg. 1822565	WARSAW, IN, United States	Manufacturer, Repacker / relabeler

Other names on FDA records

Biomet, Inc. · Biomet France · Changzhou Biomet Medical Devices Co., Ltd.

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1825034, 1822565). 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.