HomeUSABiomet Sports Medicine, Inc.

Biomet Sports Medicine, Inc.

USA · Redding
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, 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
13510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
25registered devices
Class I 9Class II 16
37 including historic records
SASaudi ArabiaSFDA
29registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
44active device licences
Class II 1Class III 43
313 including historic records
TWTaiwanTFDA
7valid device licences
Class I 1Class II 6
SGSingaporeHSA SMDR
10device registrations
CLASS B 3CLASS C 6CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
76active ARTG entries
Class I 56Class III 1IIa 13IIb 4Class Im (measuring) 2
HKHong KongMDACS
5valid listings
Class III 5
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
3active registrations
Class 1 1Class 2b 1Class 3 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 States0 registration records, 13 510(k), 0 PMA, 56 excluded
Brazil25 confirmed, 28 excluded
Saudi Arabia29 confirmed, 6 excluded
Canada44 confirmed, 12 excluded
Manufacturer names merged into this page: BIOMET ORTHOPEDICS, ATA BIOMET SPORTS MEDICINE, ATA BIOMET BIOLOGICS, ATA BIOMET TRAUMA · BIOMET SPORTS MEDICINE, INC. · BIOMET SPORTS MEDICINE · Biomet Sports Medicine, Inc · Biomet Sports Medicine

Company information

Country
USA
City
Redding

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

42007
12008
12010 · K101063
42011 · K110879
22013 · K122437
12014 · K140908

Registration details (sample)

MarketIdentifierNameClass / date
USK140908JUGGERKNOT MINI SOFT ANCHOR2014-10-02
USK122437NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS2013-10-18
USK123485JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF2013-03-18
BR80044680051INSTRUMENTAIS NÃO-ESTÉREIS, NÃO-ARTICULADOS E CORTANTES PARA ARTROSCOPClass II
BR80044680049INSTRUMENTAIS NÃO-ESTÉREIS ARTICULADOS CORTANTES PARA ARTROSCOPIA - BIClass I
BR80044680120INSTRUMENTAIS ESTÉREIS E NÃO-ARTICULADOS DE NITINOL PARA ARTROSCOPIAClass II
SAME0000001909SFDAA00091Guide Wire
SAME0000007364SFDAA00002KNOT PUSHER
CA1012ASCENT KNEE PROSTHESISClass III
CA3083REPICCI II UNICONDYLAR KNEEClass III
CA11838AGC MOLDED TIBIAL COMPONENTClass III

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