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Data / Medical devices / United States / Omnia Medical

Omnia Medical: FDA-registered device maker in Morgantown, WV, United States, 11 510(k) clearances

Omnia Medical is registered with the FDA (registration 3010560653) in Morgantown, WV, United States. It lists 19 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 6, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Omnia Medical
FDA registration number
3010560653
Address
6 Canyon Rd, Morgantown, WV, United States, 26508
Owner or operator
Omnia Medical (10045103)
Roles
Complaint file establishment, Specification developer
First device listed
October 21, 2013
Registered through
2026
Brand names listed
Boxcar, DBLogix, Disc Prep, Giza, Golden Spike, Not Available, Omnia Medical Rotary PLIF System, Omnia Medical TiBrid and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Specification developeraccessdata.fda.gov
Bit, DrillHTW1Specification developeraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Specification developeraccessdata.fda.gov
BroachHTQ1Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Specification developeraccessdata.fda.gov
Crimper, PinHXQ1Specification developeraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Complaint file establishmentaccessdata.fda.gov
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)MBP2Complaint file establishmentaccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Specification developeraccessdata.fda.gov
ScrewdriverHXX1Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 6, 2025K242431Omnia Medical PsiF DNA™ SystemOURSubstantially EquivalentOmnia Medical, LLCaccessdata.fda.gov
November 15, 2022K212612Omnia Medical TiBrid-SCOVESubstantially EquivalentOmnia Medical, LLCaccessdata.fda.gov
December 23, 2020K203207Omnia Medical TiBrid-SAOVDSubstantially EquivalentOmnia Medical, LLCaccessdata.fda.gov
February 27, 2020K192096Omnia Medical Trauma ScrewsHWCSubstantially EquivalentOmnia Medical, LLCaccessdata.fda.gov
February 21, 2020K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF CageMAXSubstantially EquivalentOmnia Medical, LLCaccessdata.fda.gov
August 28, 2019K191778Omnia Medical VBRPLRSubstantially EquivalentOmnia Medical, LLCaccessdata.fda.gov
February 6, 2019K183659Omnia Medical Rotary PLIF SystemMAXSubstantially EquivalentOmnia Medical, LLCaccessdata.fda.gov
October 26, 2017K172323Omnia Medical VBRMQPSubstantially EquivalentOmnia Medical, LLCaccessdata.fda.gov
December 22, 2016K160982Sphynx™KWQSubstantially EquivalentEden Spine, LLCaccessdata.fda.gov
May 31, 2013K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYMBPSubstantially EquivalentBacterin International, Inc.accessdata.fda.gov
January 26, 2012K112429GIZA(R) VERTEBRAL BODY REPLACEMENTMQPSubstantially EquivalentEden Spine, LLCaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 15, 202497402Class IIOngoingTiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.Failure of fusion system instruments in the field.accessdata.fda.gov

Compare with other makers

Updated September 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.