The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Navigated Disc Prep Instruments And Capstone Trials.
| Device ID | K150231 |
| 510k Number | K150231 |
| Device Name: | Navigated Disc Prep Instruments And CAPSTONE Trials |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Nicholas Tabrizi |
| Correspondent | Nicholas Tabrizi 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 | 2015-02-02 |
| Decision Date | 2015-06-16 |
| Summary: | summary |