The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa, Inc. with the FDA for Medtronic Transportation/sterilization Cassettes.
| Device ID | K163279 |
| 510k Number | K163279 |
| Device Name: | Medtronic Transportation/Sterilization Cassettes |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Medtronic Sofamor Danek, USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Julie Bassett |
| Correspondent | Julie Bassett Medtronic Sofamor Danek, USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-02-23 |
| Summary: | summary |