HomeUSANuvasive Specialized Orthopedics, Incorporated

Nuvasive Specialized Orthopedics, Incorporated

USA · Audubon
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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
23listed device types
Class I 17Class II 6Class III 0
plus 59 registration records and 25 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
14active ARTG entries
Class I 2IIa 3IIb 6Class Is (sterile) 3
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
5registrations
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 States59 registration records, 25 510(k), 0 PMA, 3 excluded
Brazil2 confirmed, 5 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: NuVasive Specialized Orthopedics, Inc. · NUVASIVE SPECIALIZED ORTHOPEDICS (GLOBUS MEDICAL, INC.) · NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Same-named companies — This database also contains companies with near-identical names: NUVASIVE SPECIALIZED ORTHOPEDICS (GLOBUS MEDICAL, INC.). Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Audubon

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

22016
82017
12018
32019
62020
32023
12024
12026

FDA listed device types

showing 8 of 23
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Growing Rod System- Magnetic Actuation 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Screwdriver 1Template 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261651Precice™ Max System and Precice™ Ankle Salvage System2026-06-18
USK233593MAGEC Spinal Bracing and Distraction System2024-02-06
USK232267Precice Max System2023-12-15
BR80074640066Instrumentais Estéreis PreciceClass I
BR80074640067Instrumentais PreciceClass I

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