The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Mastergraft Strip.
| Device ID | K082166 |
| 510k Number | K082166 |
| Device Name: | MASTERGRAFT STRIP |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-31 |
| Decision Date | 2009-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994487339 | K082166 | 000 |
| 00613994407818 | K082166 | 000 |
| 00613994407801 | K082166 | 000 |
| 00643169719385 | K082166 | 000 |
| 00643169719378 | K082166 | 000 |
| 00643169719361 | K082166 | 000 |
| 00643169486485 | K082166 | 000 |
| 00643169486478 | K082166 | 000 |
| 00643169486461 | K082166 | 000 |