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Walter Lorenz Surgical, Inc.

USA · Jacksonville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 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

56510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 56 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

12active device licences

Class II 1Class III 11

49 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

65active ARTG entries

Class I 46IIa 7IIb 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States0 registration records, 56 510(k), 0 PMA, 3 excluded

Canada12 confirmed, 1 excluded

Manufacturer names merged into this page: BIOMET MICROFIXATION ALSO TRADING AS WALTER LORENZ SURGICAL INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K063386	LORENZ ORTHODONTIC ANCHORAGE SYSTEM	2007-02-09
US	K063052	LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES	2007-01-12
US	K063506	LORENZ STERNAL CLOSURE SYSTEM	2006-12-18
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

Walter Lorenz Surgical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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