The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Navigated Elevate Inserter, Navigated Disc Prep Instruments.
| Device ID | K163581 |
| 510k Number | K163581 |
| Device Name: | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Laveeda Leflore |
| Correspondent | Laveeda Leflore 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 | 2016-12-20 |
| Decision Date | 2017-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169844070 | K163581 | 000 |
| 00763000880408 | K163581 | 000 |
| 00763000880385 | K163581 | 000 |
| 00763000124724 | K163581 | 000 |
| 00763000141400 | K163581 | 000 |
| 00763000141417 | K163581 | 000 |
| 00763000141424 | K163581 | 000 |
| 00763000124717 | K163581 | 000 |
| 00763000124700 | K163581 | 000 |
| 00763000124694 | K163581 | 000 |
| 00643169747913 | K163581 | 000 |
| 00643169747937 | K163581 | 000 |
| 00643169747951 | K163581 | 000 |
| 00643169764880 | K163581 | 000 |
| 00643169771000 | K163581 | 000 |
| 00643169771017 | K163581 | 000 |
| 00643169771024 | K163581 | 000 |
| 00643169835368 | K163581 | 000 |
| 00763000880392 | K163581 | 000 |