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SPINE INNOVATIONS

France

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Hong Kong — 5 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

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

1valid device licences

Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2Class III 2IIa 1

HKHong KongMDACS

2valid listings

Class IV 2

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 States1 registration records, 2 510(k), 0 PMA, 206 excluded

Brazil1 confirmed, 40 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 14 excluded

Manufacturer names merged into this page: SPINE INNOVATION, LLC · SPINE INNOVATIONS

Same-named companies — This database also contains companies with near-identical names: SPINE INNOVATION, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12016 · K153356

12026 · K253266

FDA listed device types

Intervertebral Fusion Device With Bone Graft, Lumbar 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253266	Titanium Interbody System	2026-01-08
US	K153356	Spine Innovation Interbody System	2016-01-14
BR	82507970034	Instrumentais CP-ESP & LP-ESP - Spine Innovations	Class I

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SPINE INNOVATIONS

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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