The following data is part of a premarket notification filed by Embody, Inc. with the FDA for Bioabsorbable Anchor.
| Device ID | K213958 |
| 510k Number | K213958 |
| Device Name: | Bioabsorbable Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810063820152 | K213958 | 000 |
| 10810063820159 | K213958 | 000 |