Omnia Medical Coupler-C Anterior Cervical Plate
FDA 510(k) K223321 · Omnia Medical, LLC
510(k) numberK223321
Submission
- Device name
- Omnia Medical Coupler-C Anterior Cervical Plate
- Applicant
- Omnia Medical, LLC
Morgantown, WV, US - Received
- October 31, 2022
- Decision date
- March 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 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 |
| 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 |
| K172323 | Omnia Medical VBRMQP · Traditional | 10/26/2017SE |
Questions and answers
When was Omnia Medical Coupler-C Anterior Cervical Plate cleared by the FDA?
Omnia Medical Coupler-C Anterior Cervical Plate (K223321) received a 510(k) decision of Substantially Equivalent on March 13, 2023, 133 days after the submission was received.
What is the product code of K223321?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.