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Home›USA›Surgical Implants, Inc.

Surgical Implants, Inc.

USA · Sarasota
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class I 6Class II 2
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
0active device licences
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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, 5 510(k), 0 PMA, 95 excluded
Brazil8 confirmed, 15 excluded
Canada0 confirmed, 13 excluded
Manufacturer names merged into this page: ZEPHYR SURGICAL IMPLANTS · TORNIER SURGICAL IMPLANTS
Same-named companies — This database also contains companies with near-identical names: ZEPHYR SURGICAL IMPLANTS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Sarasota

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

11993 · K924367
12000 · K993713
22012 · K122052
12017 · K162853

Registration details (sample)

MarketIdentifierNameClass / date
USK162853Bonafix TWO - Dental Implant System2017-07-14
USK122052MINIFIX BALL MINIFIX ONE2012-11-28
USK113650ORTHOFIX SCREW2012-10-03
BR82614020001Instrumentais Cirúrgicos para Implantação de Prótese Peniana - ZSIClass I
BR80077230006KIT INSTRUMENTAL PARA PRÓTESE DE OMBRO INVERTIDA AEQUALISClass I
BR80077230003KIT INSTRUMENTAL PARA SISTEMA DE OMBRO AEQUALIS - HASTE E CABEÇA UMERAClass II

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