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Synthes (USA) Products, LLC

USA · West Chester
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
173listed device types
Class I 93Class II 77Class III 1unclassified 2
plus 692 registration records and 485 510(k), 4 PMA
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
6active device licences
Class II 4Class III 2
32 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 States692 registration records, 485 510(k), 4 PMA, 15 excluded
Brazil0 confirmed, 5 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada6 confirmed, 2 excluded
Manufacturer names merged into this page: Synthes (USA) Products LLC · SYNTHES USA LLC
Same-named companies — This database also contains companies with near-identical names: Synthes (Usa), LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
West Chester

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

352004
312005
142006
182007
252008
192009
162010
162011
102012
52013
112014
82015
42016
82017
72018
72019
62020
32021
12022
12026

FDA listed device types

showing 8 of 173
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Cerclage, Fixation 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Washer, Bolt Nut 1Appliance, Fixation, Spinal Interlaminal 1Driver, Wire, And Bone Drill, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
USK254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System2026-06-11
USK212943SyntheCel Dura Repair2022-01-28
USK211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)2021-05-25
CA11506NAILS - STAINLESS STEELClass III
CA12040SYNCAGE INTERVERTEBRAL FUSION SYSTEMClass III
CA64905SMALL BATTERY DRIVE SETClass II

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