K131143 is an FDA 510(k) clearance for the TRELLIS COLLAGEN RIBBON. This device is classified as a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWY).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 7, 2013, 167 days after receiving the submission on April 23, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair..
| 510(k) Number | K131143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2013 |
| Decision Date | October 07, 2013 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWY — Mesh, Surgical, Collagen, 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 In Tendon Repair. |