HomeUSANEO SPINE USA INC.

NEO SPINE USA INC.

USA · Hackensack
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
17listed device types
Class I 7Class II 10Class III 0
plus 17 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
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 States17 registration records, 0 510(k), 0 PMA, 31 excluded
Brazil0 confirmed, 4 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: NEO SPINE USA INC. · NEO MEDICAL USA, INC.

Company information

Country
USA
City
Hackensack

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 listed device types

showing 8 of 17
Transducer, Ultrasonic, Diagnostic 1Thoracolumbosacral Pedicle Screw System 1Bone Cement, Posterior Screw Augmentation 1System, Imaging, Pulsed Echo, Ultrasonic 1Intervertebral Fusion Device With Bone Graft, Lumbar 1System, Imaging, Pulsed Doppler, Ultrasonic 1Light, Surgical, Instrument 1Bone Cement 1

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