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BIOMET MICROFIXATION ALSO TRADING AS WALTER LORENZ SURGICAL INC.

USA · Jacksonville

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

150listed device types

Class I 111Class II 38Class III 1

plus 188 registration records and 30 510(k), 12 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 6Class II 2

24 including historic records

SASaudi ArabiaSFDA

16registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

13active device licences

Class II 1Class III 12

50 including historic records

TWTaiwanTFDA

10valid device licences

Class I 2Class II 7Class III 1

SGSingaporeHSA SMDR

5device registrations

CLASS C 4CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

11valid listings

Class III 11

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States188 registration records, 30 510(k), 12 PMA

Brazil8 confirmed, 0 excluded

Saudi Arabia16 confirmed, 0 excluded

Canada13 confirmed, 0 excluded

Manufacturer names merged into this page: BIOMET MICROFIXATION · BIOMET MICROFIXATION ALSO TRADING AS WALTER LORENZ SURGICAL INC. · BIOMET MICROFIXATION, INC. · BIOMET MICROFIXATION, INC · Biomet Microfixation Global Headquarters · Biomet Microfixation

FDA 510(k) clearances by year

12007

12008

12009

22011

42012

32013

52015

42016

12019

22021

42022

12024

12026

FDA listed device types

showing 8 of 150

Chisel, Surgical, Manual 1Knife, Nasal 1Stripper, Surgical 1Unit, Syringe, Air And/Or Water 1Perforator, Antrum 1Accessories, Retractor, Dental 1Gag, Mouth 1Chisel, Bone, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261002	Pectus Blu System	2026-06-02
US	K241709	Pectus Blu Support Bar System	2024-09-19
US	K223199	2.1 x 255mm Drill, 22mm Stop	2022-11-15
BR	80094179004	KIT INSTRUMENTAL TMJ	Class I
BR	80094170084	Kit Instrumental SternaLock Blu	Class I
BR	80044680037	INSTRUMENTOS TMS	Class I
SA	ME0000008655SFDAA00017	CMF System ID tag removal	—
SA	ME0000008655SFDAA00085	CMF System Complete Rack SET-UP	—
CA	165	2.4 MM LOCKING RECON SYSTEM	Class III
CA	11739	LACTOSORB TRAUMA PLATING SYSTEM	Class III
CA	11882	HTR (HARD TISSUE REPLACEMENT) CRANIOFACIAL RECONSTRUCTIVE IMPLANTS	Class III

BIOMET MICROFIXATION ALSO TRADING AS WALTER LORENZ SURGICAL INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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