K250395
- 510(k) number
- K250395
- Device name
- BioBrace ® RC Delivery System
- Applicant
- Conmed Corporation NY · US
- Product code
- ORQ — Mesh, Surgical, Deployer
- Decision date
- 2025-04-07
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250395.pdf
Official FDA record: K250395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.