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Highridge Medical, LLC

USA · Westminster
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
112listed device types
Class I 68Class II 38Class III 4unclassified 2
plus 342 registration records and 2 510(k), 81 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
24registered devices
Class I 23Class II 1
62 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
16active device licences
Class II 2Class III 13Class IV 1
47 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 States342 registration records, 2 510(k), 81 PMA
Brazil24 confirmed, 0 excluded
Canada16 confirmed, 0 excluded
Manufacturer names merged into this page: Highridge Medical, LLC · HIGHRIDGE MEDICAL, LLC DBA ZIMMER BIOMET SPINE, INC. · HIGHRIDGE MEDICAL, LLC · HIGHRIDGE MEDICAL BRASIL LTDA
Same-named companies — This database also contains companies with near-identical names: HIGHRIDGE MEDICAL, LLC DBA ZIMMER BIOMET SPINE, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Westminster

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

22025 · K253093

FDA listed device types

showing 8 of 112
Electrosurgical, Cutting & Coagulation & Accessories 1Posterior Cervical Screw System 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Cerclage, Fixation 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253093Vital™ Spinal Fixation System2025-12-17
USK250332Virage® OCT Spinal Fixation System2025-04-04
BR80444810101INSTRUMENTAL MERGENCE ANTERIOR PREPARATIONClass I
BR80444810054Instrumentais Polaris 4.75Class I
BR80444810095Instrumentais The TetherClass I
CA824PRO OSTEON RESORBABLE BONE GRAFT SUBSTITUTEClass III
CA1740PRO OSTEON 200 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTEClass III
CA12556PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTEClass III

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