The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Msd Wire System.
Device ID | K020426 |
510k Number | K020426 |
Device Name: | MSD WIRE SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Richard Treharne |
Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-08 |
Decision Date | 2002-02-26 |
Summary: | summary |