Omnia Medical VBR
FDA 510(k) K191778 · Omnia Medical, LLC
510(k) numberK191778
Submission
- Device name
- Omnia Medical VBR
- Applicant
- Omnia Medical, LLC
Morgantown,, WV, US - Received
- July 2, 2019
- Decision date
- August 28, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLR – Spinal Vertebral Body Replacement Device - Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Vertebral body replacement in the cervical spine.
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|---|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | Atlas Spine, Inc. | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | Atlas Spine, Inc. | 11/10/2025SE |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional | MiRus, LLC | 10/13/2023SE |
| K221542 | Galileo Vertebral Body Replacement DevicePLR · Special | Bright Spine | 01/13/2023SE |
| K212126 | MediExpand Cervical Expandable VBR SystemPLR · Traditional | Cmf Medicon Surgical, Inc. | 04/04/2022SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | K2m, Inc. | 02/24/2022SE |
| K192145 | Galileo Vertebral Body Replacement DevicePLR · Traditional | Bright Spine | 04/21/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | Nexxt Spine, LLC | 02/24/2020SE |
| K190284 | Bengal Stackable Cage SystemPLR · Traditional | Medos International SARL | 12/20/2019SE |
| K190426 | ALTA Anterior Cervical Corpectomy SystemPLR · Traditional | Astura Medical, LLC | 10/24/2019SE |
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| 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 |
| K183659 | Omnia Medical Rotary PLIF SystemMAX · Traditional | 02/06/2019SE |
| K172323 | Omnia Medical VBRMQP · Traditional | 10/26/2017SE |
Questions and answers
When was Omnia Medical VBR cleared by the FDA?
Omnia Medical VBR (K191778) received a 510(k) decision of Substantially Equivalent on August 28, 2019, 57 days after the submission was received.
What is the product code of K191778?
The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.