K242187 is an FDA 510(k) clearance for the BioBrace®. This device is classified as a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWW).
Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on November 27, 2024, 125 days after receiving the submission on July 25, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures..
| 510(k) Number | K242187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2024 |
| Decision Date | November 27, 2024 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures. |