The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Mastergraft Resorbable Ceramic Granules.
| Device ID | K012506 |
| 510k Number | K012506 |
| Device Name: | MASTERGRAFT RESORBABLE CERAMIC GRANULES |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne 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 | 2001-08-06 |
| Decision Date | 2002-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902184994 | K012506 | 000 |
| 00721902184987 | K012506 | 000 |
| 00721902168741 | K012506 | 000 |
| 00721902168734 | K012506 | 000 |