The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Msd Cable Reduction System.
Device ID | K030816 |
510k Number | K030816 |
Device Name: | MSD CABLE REDUCTION SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Richard Treharne |
Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-14 |
Decision Date | 2003-06-06 |
Summary: | summary |