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EXACTECH, INC.

USA · Gainesville

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia — 6 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

63listed device types

Class I 34Class II 27Class III 2

plus 173 registration records and 186 510(k), 21 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

28registered devices

Class I 23Class II 5

44 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 1Class III 3

19 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

77active ARTG entries

Class I 2Class III 47IIa 21IIb 7

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 States173 registration records, 186 510(k), 21 PMA, 2 excluded

Brazil28 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: EXACTECH, INC. · EXACTECH INC. · EXACTECH INC · EXACTECH, INC

FDA 510(k) clearances by year

52006

52007

52008

12009

142010

102011

82012

82013

82014

92015

62016

62017

82018

42019

22020

12022

62023

22024

42025

12026

FDA listed device types

showing 8 of 63

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous 1Bone Grafting Material, Human Source 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260583	Equinoxe® Shoulder System	2026-04-14
US	K250713	Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants	2025-12-01
US	K243448	Equinoxe® Shoulder System	2025-08-01
BR	80102519112	INSTRUMENTAIS PARA PRÓTESE DE OMBRO EXACTECH	Class II
BR	80102512460	INSTRUMENTOS DE OMBRO EXACTECH	Class I
BR	80102512461	INSTRUMENTOS DE QUADRIL EXACTECH	Class II
CA	70475	OPTETRAK HI-FLEX KNEE SYSTEM	Class III
CA	70476	OPTETRAK TOTAL KNEE SYSTEM	Class III
CA	87488	OPTETRAK HI-FLEX TIBIAL INSERTS	Class III

EXACTECH, 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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