The following data is part of a premarket notification filed by Biocomposites Ltd with the FDA for Genex Bone Graft Substitute.
| Device ID | K212721 |
| 510k Number | K212721 |
| Device Name: | Genex Bone Graft Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Biocomposites Ltd Keele Science Park Keele, GB St5 5nl |
| Contact | Simon Fitzer |
| Correspondent | Simon Fitzer Biocomposites Ltd Keele Science Park Keele, GB St5 5nl |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-27 |
| Decision Date | 2022-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060155711499 | K212721 | 000 |
| 15060155711482 | K212721 | 000 |
| 15060155711475 | K212721 | 000 |