The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Mastergraft Resorbable Ceramic Granules.
| Device ID | K082917 |
| 510k Number | K082917 |
| Device Name: | MASTERGRAFT RESORBABLE CERAMIC GRANULES |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 -3576 |
| Contact | Ryan Massey |
| Correspondent | Ryan Massey MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 -3576 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2009-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994512826 | K082917 | 000 |
| 00613994512819 | K082917 | 000 |
| 00613994512802 | K082917 | 000 |
| 00613994512796 | K082917 | 000 |
| 00613994512789 | K082917 | 000 |
| 00613994512772 | K082917 | 000 |
| 00613994512765 | K082917 | 000 |
| 00613994512758 | K082917 | 000 |