K201572 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 October 19, 2020, 130 days after receiving the submission on June 11, 2020.
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 | K201572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2020 |
| Decision Date | October 19, 2020 |
| Days to Decision | 130 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. |