The following data is part of a premarket notification filed by Surgentec, Llc with the FDA for Osteoflo Nanoputty-quadphasic Synthetic Bone Graft.
| Device ID | K200064 |
| 510k Number | K200064 |
| Device Name: | OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SurGenTec, LLC 911 Clint Moore Rd Boca Raton, FL 33487 |
| Contact | Travis Greenhalgh |
| Correspondent | Travis Greenhalgh SurGenTec, LLC 911 Clint Moore Rd Boca Raton, FL 33487 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-08-14 |