The following data is part of a premarket notification filed by Embody, Inc. with the FDA for Tapestry Biointegrative Implant.
| Device ID | K220867 |
| 510k Number | K220867 |
| Device Name: | Tapestry Biointegrative Implant |
| Classification | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| Applicant | Embody, Inc. 4211 Monarch Way Suite 500 Norfolk, VA 23508 |
| Contact | Brianna Schehr |
| Correspondent | Brianna Schehr Embody, Inc. 4211 Monarch Way Suite 500 Norfolk, VA 23508 |
| Product Code | OWY |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-25 |
| Decision Date | 2022-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810063820145 | K220867 | 000 |
| 00810063820138 | K220867 | 000 |
| 00810063820121 | K220867 | 000 |
| 00810063820114 | K220867 | 000 |
| 00810063820107 | K220867 | 000 |
| 00810063820091 | K220867 | 000 |
| 00810063820466 | K220867 | 000 |
| 00810063820459 | K220867 | 000 |