The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Navigated Vertex Select Instruments.
| Device ID | K143628 |
| 510k Number | K143628 |
| Device Name: | Navigated Vertex Select Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Tejas Patel |
| Correspondent | Tejas Patel 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 | 2014-12-22 |
| Decision Date | 2015-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169713369 | K143628 | 000 |
| 00643169474864 | K143628 | 000 |
| 00643169474871 | K143628 | 000 |
| 00643169474888 | K143628 | 000 |
| 00643169474895 | K143628 | 000 |
| 00643169518414 | K143628 | 000 |
| 00643169672819 | K143628 | 000 |
| 00643169672826 | K143628 | 000 |
| 00643169672833 | K143628 | 000 |
| 00643169672840 | K143628 | 000 |
| 00643169672857 | K143628 | 000 |
| 00643169672864 | K143628 | 000 |
| 00643169713352 | K143628 | 000 |
| 00643169474857 | K143628 | 000 |