K212306 is an FDA 510(k) clearance for the Tapestry Biointegrative Implant. This device is classified as a Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWY).
Submitted by Embody, Inc. (Norfolk, US). The FDA issued a Cleared decision on November 2, 2021, 102 days after receiving the submission on July 23, 2021.
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 | K212306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2021 |
| Decision Date | November 02, 2021 |
| Days to Decision | 102 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. |