The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa Inc with the FDA for Navigated T2 Stratosphere Inserters And Navigated Templates.
| Device ID | K191039 |
| 510k Number | K191039 |
| Device Name: | Navigated T2 STRATOSPHERE Inserters And Navigated Templates |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2019-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000091255 | K191039 | 000 |
| 00763000091248 | K191039 | 000 |
| 00643169611900 | K191039 | 000 |
| 00643169611894 | K191039 | 000 |
| 00643169611870 | K191039 | 000 |
| 00643169611863 | K191039 | 000 |
| 00643169611825 | K191039 | 000 |
| 00763000168711 | K191039 | 000 |