Optio-C Anterior Cervical System
FDA 510(k) K141500 · Zimmer Spine, Inc.
510(k) numberK141500
Submission
- Device name
- Optio-C Anterior Cervical System
- Applicant
- Zimmer Spine, Inc.
Minneapolis, MN, US - Received
- June 6, 2014
- Decision date
- September 23, 2014
- 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 |
|---|---|---|
| K153631 | Zimmer Virage OCT Spinal Fixation SystemNKG · Special | 02/16/2016SE |
| K150896 | Vitality Spinal Fixation SystemNKB · Traditional | 08/31/2015SE |
| K151031 | Virage OCT Spinal Fixation SystemNKG · Traditional | 06/24/2015SE |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…NKB · Traditional | 06/18/2015SE |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…KWQ · Traditional | 03/20/2015SE |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…MAX · Traditional | 02/12/2015SE |
| K142053 | Universal Clamp Spinal Fixation SystemOWI · Traditional | 10/29/2014SE |
| K133556 | Virage Oct Spinal Fixation SystemKWP · Traditional | 06/02/2014SE |
| K140611 | Trinica Anterior Lumbar Plate SystemKWQ · Traditional | 05/21/2014SE |
| K133184 | Ardis Interbody SystemMAX · Traditional | 01/30/2014SE |
Questions and answers
When was Optio-C Anterior Cervical System cleared by the FDA?
Optio-C Anterior Cervical System (K141500) received a 510(k) decision of Substantially Equivalent on September 23, 2014, 109 days after the submission was received.
What is the product code of K141500?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.