The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Uniplate Anterior Cervical Plate System.
Device ID | K042544 |
510k Number | K042544 |
Device Name: | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Sharon Starowicz |
Correspondent | Sharon Starowicz DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-20 |
Decision Date | 2004-11-23 |
Summary: | summary |