HomeUSALife Spine, Inc.

Life Spine, Inc.

USA · Huntley
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Israel — 4 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
22listed device types
Class I 2Class II 20Class III 0
plus 105 registration records and 123 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 3
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States105 registration records, 123 510(k), 0 PMA, 204 excluded
Brazil3 confirmed, 39 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 14 excluded
Manufacturer names merged into this page: LIFE SPINE · LIFE SPINE, INC.

Company information

Country
USA
City
Huntley

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

32007
62008
52009
32010
42011
52012
72013
52014
102015
62016
102017
102018
72019
92020
62021
52022
42023
32024
32025
52026

FDA listed device types

showing 8 of 22
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Intervertebral Fusion Device With Integrated Fixation, Cervical 1Appliance, Fixation, Spinal Interlaminal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261430TruLift Expandable System2026-07-28
USK260571SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments2026-06-02
USK260837VersaLift Expandable System2026-05-12
BR10364319005INSTRUMENTAL PARA O SISTEMA DE FIXAÇÃO DE COLUNA VERTEBRAL CONQUESTClass I
BR81625530001Instrumental AvatarClass I
BR81625530002Instrumental SimpactClass I

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