The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Genex Putty.
| Device ID | K073341 |
| 510k Number | K073341 |
| Device Name: | GENEX PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Contact | Simon Fitzer |
| Correspondent | Simon Fitzer BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, 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 | 2007-11-28 |
| Decision Date | 2008-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50601557101810 | K073341 | 000 |
| 50601557101742 | K073341 | 000 |
| 50601557101674 | K073341 | 000 |