Omnia Medical VBR
FDA 510(k) K172323 · Omnia Medical, LLC
510(k) numberK172323
Submission
- Device name
- Omnia Medical VBR
- Applicant
- Omnia Medical, LLC
Morgantown, WV, US - Received
- August 1, 2017
- Decision date
- October 26, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K242431 | Omnia Medical PsiF DNA SystemOUR · Traditional | 06/06/2025SE |
| K240623 | Omnia Medical TiBrid-SA SystemOVD · Traditional | 04/24/2024SE |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral…KWQ · Traditional | 04/12/2023SE |
| K223321 | Omnia Medical Coupler-C Anterior Cervical PlateKWQ · Traditional | 03/13/2023SE |
| K212612 | Omnia Medical TiBrid-SCOVE · Traditional | 11/15/2022SE |
| K203207 | Omnia Medical TiBrid-SAOVD · Traditional | 12/23/2020SE |
| K192096 | Omnia Medical Trauma ScrewsHWC · Traditional | 02/27/2020SE |
| K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical…MAX · Traditional | 02/21/2020SE |
| K191778 | Omnia Medical VBRPLR · Special | 08/28/2019SE |
| K183659 | Omnia Medical Rotary PLIF SystemMAX · Traditional | 02/06/2019SE |
Questions and answers
When was Omnia Medical VBR cleared by the FDA?
Omnia Medical VBR (K172323) received a 510(k) decision of Substantially Equivalent on October 26, 2017, 86 days after the submission was received.
What is the product code of K172323?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.