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Home›China›Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.

Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.

China · Changzhou Jiangsu
✓ 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
10listed device types
Class I 3Class II 7Class III 0
plus 12 registration records and 2 510(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 States12 registration records, 2 510(k), 0 PMA
Manufacturer names merged into this page: Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.
Same-named companies — This database also contains companies with near-identical names: Changzhou Orthmed Medical Instrument Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Changzhou Jiangsu

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

12010 · K101400
12011 · K111690

FDA listed device types

showing 8 of 10
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer 1Screw, Fixation, Bone 1Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Shoulder Prosthesis, Reverse Configuration 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK111690DEVINE SPINAL SYSTEM2011-11-22
USK101400LOCKING COMPRESSION PLATE2010-11-09

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