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 | K100070 |
510k Number | K100070 |
Device Name: | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Christopher Rogers |
Correspondent | Christopher Rogers DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-11 |
Decision Date | 2010-02-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10705034295213 | K100070 | 000 |
10705034295190 | K100070 | 000 |
10705034295145 | K100070 | 000 |
10705034295206 | K100070 | 000 |
10705034295183 | K100070 | 000 |
10705034295176 | K100070 | 000 |
10705034295169 | K100070 | 000 |
10705034295152 | K100070 | 000 |