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 | K190840 |
| 510k Number | K190840 |
| 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 | Elizabeth Hamilton |
| Correspondent | Elizabeth Hamilton 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 | 2019-04-01 |
| Decision Date | 2019-10-15 |