The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Progenix Dbm Putty And Paste.
| Device ID | K060794 |
| 510k Number | K060794 |
| Device Name: | PROGENIX DBM PUTTY AND PASTE |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Edward S Chin |
| Correspondent | Edward S Chin MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-23 |
| Decision Date | 2006-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994236425 | K060794 | 000 |
| 00613994236418 | K060794 | 000 |
| 00613994236401 | K060794 | 000 |
| 00613994247612 | K060794 | 000 |
| 00763000140533 | K060794 | 000 |
| 00763000140526 | K060794 | 000 |
| 00763000140519 | K060794 | 000 |
| 00763000140502 | K060794 | 000 |