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 | K082273 |
510k Number | K082273 |
Device Name: | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Frank Jurczak |
Correspondent | Frank Jurczak 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 | 2008-08-11 |
Decision Date | 2008-09-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10705034181189 | K082273 | 000 |
10705034181134 | K082273 | 000 |
10705034181141 | K082273 | 000 |
10705034181158 | K082273 | 000 |
10705034181165 | K082273 | 000 |
10705034181172 | K082273 | 000 |
10705034181196 | K082273 | 000 |
10705034181202 | K082273 | 000 |
10705034181219 | K082273 | 000 |
10705034181226 | K082273 | 000 |
10705034181233 | K082273 | 000 |
10705034181240 | K082273 | 000 |
10705034181257 | K082273 | 000 |
10705034181264 | K082273 | 000 |
10705034181271 | K082273 | 000 |
10705034181288 | K082273 | 000 |
10705034181127 | K082273 | 000 |