The following data is part of a premarket notification filed by Depuy Spine,inc with the FDA for Swift Plus Anterior Cervical Plate System.
Device ID | K072546 |
510k Number | K072546 |
Device Name: | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | DEPUY SPINE,INC 325 PARAMONT DRIVE Raynham, MA 02767 |
Contact | Frank S Jurczak |
Correspondent | Frank S Jurczak DEPUY SPINE,INC 325 PARAMONT DRIVE 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 | 2007-09-10 |
Decision Date | 2007-10-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10705034095202 | K072546 | 000 |
10705034094663 | K072546 | 000 |
10705034094670 | K072546 | 000 |
10705034094687 | K072546 | 000 |
10705034094694 | K072546 | 000 |
10705034094700 | K072546 | 000 |
10705034094717 | K072546 | 000 |
10705034094731 | K072546 | 000 |
10705034094748 | K072546 | 000 |
10705034094656 | K072546 | 000 |
10705034094649 | K072546 | 000 |
10705034095295 | K072546 | 000 |
10705034095219 | K072546 | 000 |
10705034095226 | K072546 | 000 |
10705034095233 | K072546 | 000 |
10705034095240 | K072546 | 000 |
10705034095257 | K072546 | 000 |
10705034095264 | K072546 | 000 |
10705034095271 | K072546 | 000 |
10705034095288 | K072546 | 000 |
10705034094755 | K072546 | 000 |
10705034094762 | K072546 | 000 |
10705034094779 | K072546 | 000 |
10705034095066 | K072546 | 000 |
10705034095080 | K072546 | 000 |
10705034095103 | K072546 | 000 |
10705034095127 | K072546 | 000 |
10705034095158 | K072546 | 000 |
10705034095165 | K072546 | 000 |
10705034095172 | K072546 | 000 |
10705034095189 | K072546 | 000 |
10705034095028 | K072546 | 000 |
10705034095004 | K072546 | 000 |
10705034094984 | K072546 | 000 |
10705034094786 | K072546 | 000 |
10705034094847 | K072546 | 000 |
10705034094854 | K072546 | 000 |
10705034094861 | K072546 | 000 |
10705034094878 | K072546 | 000 |
10705034094885 | K072546 | 000 |
10705034094892 | K072546 | 000 |
10705034094960 | K072546 | 000 |
10705034095196 | K072546 | 000 |