corra cervical plating system
FDA 510(k) K260570 · Carlsmed, Inc.
510(k) numberK260570
Submission
- Device name
- corra cervical plating system
- Applicant
- Carlsmed, Inc.
Carlsbad, CA, US - Received
- February 19, 2026
- Decision date
- April 22, 2026
- 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 |
| 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 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | Alphatec Spine, Inc. | 08/28/2025SE |
More from Alphatec Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…MAX · Traditional | 05/09/2026SE |
| K252894 | aprevo® cervical interbody systemODP · Traditional | 01/06/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | 12/22/2025SE |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…MAX · Traditional | 07/07/2025SE |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion deviceMAX · Traditional | 06/30/2025SE |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…OVD · Traditional | 03/17/2025SE |
| K242599 | aprevo® Digital PlanningLLZ · Traditional | 12/20/2024SE |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixationOVD · Special | 12/13/2024SE |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMODP · Traditional | 11/15/2024SE |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixationOVD · Traditional | 10/09/2024SE |
Questions and answers
When was corra cervical plating system cleared by the FDA?
corra cervical plating system (K260570) received a 510(k) decision of Substantially Equivalent on April 22, 2026, 62 days after the submission was received.
What is the product code of K260570?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.