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NEO MEDICAL USA, INC.

USA · San Jose

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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

29listed device types

Class I 9Class II 20Class III 0

plus 56 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

1active device licences

Class III 1

8 including historic records

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 States56 registration records, 6 510(k), 0 PMA, 28 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada1 confirmed, 3 excluded

Manufacturer names merged into this page: NEO SPINE USA INC. · NEO MEDICAL S.A. · NEO MEDICAL INC. · NEO MEDICAL USA, INC. · NEO-MEDICAL CO., LTD.

FDA 510(k) clearances by year

12017 · K171582

22019 · K191796

12021 · K212489

12022 · K222256

12024 · K243693

FDA listed device types

showing 8 of 29

Thoracolumbosacral Pedicle Screw System 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Light, Surgical, Instrument 1Needle, Hypodermic, Single Lumen 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Bone Cement, Posterior Screw Augmentation 1System, Imaging, Pulsed Doppler, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243693	NEO Pedicle Screw System	2024-12-23
US	K222256	BonOs® Inject Bone Cement; NEO Pedicle Screw System	2022-08-26
US	K212489	BonOs Inject Bone Cement; NEO Pedicle Screw System	2021-10-28
SA	ME0000012244SFDAA00003	MOVE ON FREEZE	—
CA	84602	V-CATH PICC CATHETER ONLY	Class III

NEO MEDICAL USA, 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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