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NUVASIVE, INC.

USA · San Diego

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 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

66listed device types

Class I 19Class II 45Class III 1unclassified 1

plus 326 registration records and 92 510(k), 26 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

46registered devices

Class I 32Class II 14

63 including historic records

SASaudi ArabiaSFDA

36registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 1Class III 1

6 including historic records

TWTaiwanTFDA

9valid device licences

Class I 1Class II 8

SGSingaporeHSA SMDR

40device registrations

CLASS B 5CLASS C 33CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

39active ARTG entries

Class I 5Class III 1IIa 12IIb 19Class Is (sterile) 2

HKHong KongMDACS

7valid listings

Class II 1Class III 5Class IV 1

ILIsraelAMAR

7registrations

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 States326 registration records, 92 510(k), 26 PMA, 4 excluded

Brazil46 confirmed, 2 excluded

Saudi Arabia36 confirmed, 0 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: NUVASIVE, INC. · NUVASIVE INC. · NUVASIVE, INC · NUVASIVE · NuVasive Inc.

FDA 510(k) clearances by year

32000

22001

22002

42003

42004

42005

62006

92007

62008

92009

62010

62011

92012

92013

42014

22015

12017

12021

12023

22024

FDA listed device types

showing 8 of 66

Template 1Forceps 1Elevator 1Impactor 1Screwdriver 1Gauge, Depth 1Orthopedic Manual Surgical Instrument 1Wrench 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233706	Bendini Cloud Application	2024-08-02
US	K240507	NuVasive AttraX Scaffold	2024-03-20
US	K223731	NuVasive Modulus-C Interbody System	2023-01-12
BR	80074649008	Kit Instrumentais Reline	Class II
BR	80074640061	Kit Instrumentais Modulus	Class I
BR	80074640059	Maxcess Revolution Access	Class I
SA	ME0000005437SFDAA00185	Universal Broach, Guided	—
SA	ME0000005437SFDAA00189	CoRoent LC Tamp, Pronged	—
CA	74164	PCM ARTIFICIAL CERVICAL DISC IMPLANT SYSTEM	Class III
CA	75956	NEUROVISION JJB SYSTEM	Class II

NUVASIVE, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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