corra® cervical plating system— 510(k) K262149
Substantially EquivalentCarlsmed, Inc.
FDA 510(k) clearance K262149 for corra® cervical plating system, Substantially Equivalent on 2026-09-24. Applicant: Carlsmed, Inc.. Device class: 2.
Summary
The corra cervical plating system from Carlsmed, Inc. is filed under KWQ, spinal intervertebral body fixation appliances. The record doesn't describe the plate design or levels treated.
Class II, 21 CFR 888.3060. The Orthopedic panel reviewed it as a Traditional 510(k).
Carlsmed filed from Carlsbad, California. Review took 91 days (June 25 to September 24, 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.