The following data is part of a premarket notification filed by Zavation Medical Products, Llc with the FDA for Uni-fuze-p Bone Putty.
| Device ID | K201781 |
| 510k Number | K201781 |
| Device Name: | Uni-FuZe-P Bone Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Zavation Medical Products, LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Contact | Steve Gordon |
| Correspondent | Robert A. Poggie BioVera Inc. 65 Promenade Saint Louis Notre-dame-del-l'ile-perrot, CA J7v 7p2 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2020-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842166186040 | K201781 | 000 |
| 00842166186033 | K201781 | 000 |
| 00842166186026 | K201781 | 000 |