The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Progenix Dbm Putty.
| Device ID | K080462 |
| 510k Number | K080462 |
| Device Name: | PROGENIX DBM PUTTY |
| Classification | Bone Grafting Material, Human Source |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Michelle Obenauer |
| Correspondent | Michelle Obenauer MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-20 |
| Decision Date | 2008-05-13 |
| Summary: | summary |