The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Mastergraft Putty.
| Device ID | K140374 |
| 510k Number | K140374 |
| Device Name: | MASTERGRAFT PUTTY |
| Classification | Bone Grafting Material, Synthetic |
| 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 | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169486454 | K140374 | 000 |
| 00885074478753 | K140374 | 000 |
| 00885074478760 | K140374 | 000 |
| 00885074478784 | K140374 | 000 |
| 00885074478791 | K140374 | 000 |
| 00643169486416 | K140374 | 000 |
| 00643169486423 | K140374 | 000 |
| 00643169486430 | K140374 | 000 |
| 00643169486447 | K140374 | 000 |
| 00885074478715 | K140374 | 000 |