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Home›Switzerland›STRYKER SPINE S.A.

STRYKER SPINE S.A.

Switzerland
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 9 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
38listed device types
Class I 11Class II 26Class III 0unclassified 1
plus 229 registration records and 75 510(k), 17 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
25registered devices
Class I 20Class II 5
38 including historic records
SASaudi ArabiaSFDA
83registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
36active device licences
Class II 4Class III 32
101 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
17device registrations
CLASS B 1CLASS C 13CLASS D 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
97active ARTG entries
Class I 52Class III 2IIa 11IIb 20Class Im (measuring) 12
HKHong KongMDACS
10valid listings
Class II 1Class III 8Class IV 1
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
6active registrations
Class 2a 3Class 2b 1Class 3 2
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 States229 registration records, 75 510(k), 17 PMA, 78 excluded
Brazil25 confirmed, 20 excluded
Saudi Arabia83 confirmed, 8 excluded
Canada36 confirmed, 14 excluded
Manufacturer names merged into this page: STRYKER SPINE · STRYKER SPINE SAS · STRYKER SPINE S.A. · Stryker Spine · STRYKER SPINE SA
Same-named companies — This database also contains companies with near-identical names: STRYKER SPINE SAS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Switzerland

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

22004
132005
132006
42007
62008
52009
72010
22011
72012
22013
12015
12016
12017
12018
22019
12020
12021
22023
22024
22026

FDA listed device types

showing 8 of 38
Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Neurological Stereotaxic Instrument 1Neurosurgical Nerve Locator 1Intervertebral Fusion Device With Integrated Fixation, Cervical 1Appliance, Fixation, Spinal Interlaminal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM2026-07-17
USK261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute2026-04-24
USK242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI2024-11-07
BR80005430160INSTRUMENTAL STRYKER PARA FIXAÇÃO DE COLUNAClass I
BR80005430460INSTRUMENTAIS DE POLISULFONA (PPSU) STRYKERClass I
BR80005430178INSTRUMENTAL STRYKER PARA CIRURGIA INTERSOMÁTICA DE COLUNAClass I
SAME0000009395SFDAA00008RELIANCE® T-HANDLE—
SAME0000007157SFDAA00001ES2 Spinal—
CA926XIA SPINAL FIXATION SYSTEMClass III
CA1547OSTEONICS ODC-X CEMENTED HIP STEM SERIESClass III
CA4319OSTEONICS RESTORATION HA HIP STEMSClass III

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