The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Progenix Plus.
| Device ID | K081950 |
| 510k Number | K081950 |
| Device Name: | PROGENIX PLUS |
| Classification | Bone Grafting Material, Human Source |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Ryan Massey |
| Correspondent | Ryan Massey MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-09 |
| Decision Date | 2008-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994391049 | K081950 | 000 |
| 00613994391032 | K081950 | 000 |
| 00613994391025 | K081950 | 000 |
| 00613994391018 | K081950 | 000 |
| 00763000140571 | K081950 | 000 |
| 00763000140564 | K081950 | 000 |
| 00763000140557 | K081950 | 000 |
| 00763000140540 | K081950 | 000 |