K252946
- 510(k) number
- K252946
- Device name
- BioBrace® Extra-Articular Ligament Augmentation Kit
- Applicant
- Conmed Corporation NY · US
- Product code
- MAI — Fastener, Fixation, Biodegradable, Soft Tissue
- Decision date
- 2025-10-15
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252946.pdf
Official FDA record: K252946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.