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Omnia Medical, LLC

USA · Morgantown

✓ 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

20listed device types

Class I 8Class II 12Class III 0

plus 20 registration records and 11 510(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 States20 registration records, 11 510(k), 0 PMA, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Omnia Medical · OMNIA INVENTA MEDICAL, INC.

FDA 510(k) clearances by year

12017

22019

32020

12022

22023

12024

12025

FDA listed device types

showing 8 of 20

Filler, Bone Void, Calcium Compound 1Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) 1Catheter And Tip, Suction 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Intervertebral Fusion Device With Integrated Fixation, Lumbar 1Spinal Vertebral Body Replacement Device 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242431	Omnia Medical PsiF DNA System	2025-06-06
US	K240623	Omnia Medical TiBrid-SA System	2024-04-24
US	K230424	Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System	2023-04-12

Omnia Medical, LLC

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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