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Home›USA›Response Ortho Solutions, LLC

Response Ortho Solutions, LLC

USA · Boynton Beach
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
1listed device types
Class I 0Class II 1Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class I 13
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
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 States2 registration records, 2 510(k), 0 PMA, 8 excluded
Brazil13 confirmed, 2 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: RESPONSE ORTHO SOLUTIONS LLC · RESPONSE ORTHO LLC · RESPONSE ORTHO TEKNOLOJIK URETIM A S
Same-named companies — This database also contains companies with near-identical names: RESPONSE ORTHO LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Boynton Beach

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

12024 · K241769
12025 · K252625

FDA listed device types

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252625The Response Ortho Smart Fixator - Hexapod System2025-11-20
USK241769Response Ortho Metaphyseal Hinge Fixator System2024-09-18
BR80012450033FIXADORES EXTERNOS UniX MULTIARTICULADOSClass I
BR80718160021FIXADOR EXTERNO CIRCULAR HEXAPOD SMART CORRECTIONClass I
BR80012450020Fixadores Externos Smart CorrectionClass I

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