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Home›USA›Orthopedic Designs North America, Inc.

Orthopedic Designs North America, Inc.

USA · Tampa
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
15listed device types
Class I 11Class II 4Class III 0
plus 22 registration records and 10 510(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
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 States22 registration records, 10 510(k), 0 PMA, 69 excluded
Brazil0 confirmed, 3 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: Orthopedic Designs North America, Inc.
Same-named companies — This database also contains companies with near-identical names: Orthopedic Designs, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Tampa

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

11998
11999
12002
12003
12004
12011
12015
12018
12022
12024

FDA listed device types

showing 8 of 15
Screw, Fixation, Bone 1Rod, Fixation, Intramedullary And Accessories 1Nail, Fixation, Bone 1Washer, Bolt Nut 1Template 1Reamer 1Wrench 1Bit, Drill 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241484Atlas™ Humeral Nail System2024-11-05
USK210146Cannulated Compression Device System2022-04-13
USK173255Talon DistalFix Humeral Nail2018-02-22

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