The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Mastergraft Contain.
| Device ID | K151172 |
| 510k Number | K151172 |
| Device Name: | MASTERGRAFT Contain |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Gregory K Maschek |
| Correspondent | Gregory K Maschek 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 | 2015-05-01 |
| Decision Date | 2015-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169585478 | K151172 | 000 |
| 00643169585461 | K151172 | 000 |
| 00643169585454 | K151172 | 000 |
| 00643169585447 | K151172 | 000 |