The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Venture Anterior Cervical Plating System.
Device ID | K042922 |
510k Number | K042922 |
Device Name: | VENTURE ANTERIOR CERVICAL PLATING SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
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 | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-22 |
Decision Date | 2004-11-19 |
Summary: | summary |