The following data is part of a premarket notification filed by Depuy Motech Acromed with the FDA for Doc Ventral Cervical Stabilization System.
Device ID | K982443 |
510k Number | K982443 |
Device Name: | DOC VENTRAL CERVICAL STABILIZATION SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | DEPUY MOTECH ACROMED 3303 CARNEGIE AVE. Cleveland, OH 44115 |
Contact | William Christianson |
Correspondent | William Christianson DEPUY MOTECH ACROMED 3303 CARNEGIE AVE. Cleveland, OH 44115 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-14 |
Decision Date | 1998-07-29 |
Summary: | summary |