The following data is part of a premarket notification filed by Embody, Inc. with the FDA for Tapestry Biointegrative Implant.
| Device ID | K201572 |
| 510k Number | K201572 |
| Device Name: | TAPESTRY Biointegrative Implant |
| Classification | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| Applicant | Embody, Inc. 4211 Monarch Way, Ste 500 Norfolk, VA 23508 |
| Contact | Scott Bruder |
| Correspondent | Scott Bruder Bruder Consulting And Venture Group 4211 Monarch Way, Ste. 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 | 2020-06-11 |
| Decision Date | 2020-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810063820053 | K201572 | 000 |
| 00810063820046 | K201572 | 000 |
| 00810063820022 | K201572 | 000 |
| 00810063820015 | K201572 | 000 |
| 00810063820008 | K201572 | 000 |
| 00810063820060 | K201572 | 000 |
| 00810063820084 | K201572 | 000 |
| 00810063820077 | K201572 | 000 |
| 00810063820039 | K201572 | 000 |