Omnia Medical

FDA Device Registration & Listing · MORGANTOWN, WV, US · Registration 3010560653

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010560653
FEI Number
3010560653
Entity Name
Omnia Medical
City/State/Country
MORGANTOWN, WV, US
Establishment Address
6 Canyon Rd, MORGANTOWN, WV 26508, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Omnia Medical (Owner Number: 10045103)
Owner / Operator Contact Address
6 Canyon Road, Suite 300, Morgantown, WV 26508, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Omnia Medical Trays Giza PsiF DNA Omnia Medical VBR Boxcar Pedicle Screw Removal Tool PSIF Orthocision Golden Spike Not Available Not Available Not Available

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-06-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2020-12-29
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2025-08-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-12-27
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-12-16
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2019-12-16
HXX Screwdriver Orthopedic Class 1 888.4540 2020-02-25
HTQ Broach Orthopedic Class 1 888.4540 2013-10-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-03-05
HXQ Crimper, Pin Orthopedic Class 1 888.4540 2015-01-06
HTW Bit, Drill Orthopedic Class 1 888.4540 2015-01-06
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2015-01-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Omnia Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10
K211892 Arftx Medical, LLC ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) 2022-10-06
K070082 Vertebration,Inc XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY 2007-04-20
K051027 Surgicraft , Ltd. STALIF TT 2005-06-29
K213667 SI-BONE, Inc. iFuse-TORQ® Implant System 2022-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010560653. Last updated year: 2026. Please use registration number 3010560653 when referencing this establishment in official correspondence.
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