The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Mastergraft Putty, Mastergraft Strip.
| Device ID | K140375 |
| 510k Number | K140375 |
| Device Name: | MASTERGRAFT PUTTY, MASTERGRAFT STRIP |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Kelly Anglin |
| Correspondent | Kelly Anglin MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-04-18 |
| Summary: | summary |