The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Mastergraft Strip; Mastergraft Ultramatrix.
| Device ID | K130335 |
| 510k Number | K130335 |
| Device Name: | MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Ryan Massey |
| Correspondent | Ryan Massey MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-11 |
| Decision Date | 2013-04-19 |
| Summary: | summary |