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 |