corra cervical plating system— 510(k) K260570
Substantially EquivalentCarlsmed, Inc.
FDA 510(k) clearance K260570 for corra cervical plating system, Substantially Equivalent on 2026-04-22. Applicant: Carlsmed, Inc.. Device class: 2.
Summary
Carlsmed's corra cervical plating system is filed under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Carlsmed filed from Carlsbad, California. The decision came 62 calendar days after FDA received it (February 19 to April 22, 2026).
Clearance details
- Applicant
- Carlsmed, Inc.
- Product code
- Product code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code KWQ
view allMore clearances from Carlsmed, Inc.
view allAdverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.