The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Modification To Cd Horizon Spinal System.
Device ID | K091974 |
510k Number | K091974 |
Device Name: | MODIFICATION TO CD HORIZON SPINAL SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Chris Mckee |
Correspondent | Chris Mckee MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
Subsequent Product Code | NQP |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-01 |
Decision Date | 2009-09-02 |
Summary: | summary |