The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Viper F2 Facet Fixation System.
Device ID | K101762 |
510k Number | K101762 |
Device Name: | VIPER F2 FACET FIXATION SYSTEM |
Classification | System, Facet Screw Spinal Device |
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 | MRW |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-22 |
Decision Date | 2010-11-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10705034034768 | K101762 | 000 |
10705034034850 | K101762 | 000 |
10705034034836 | K101762 | 000 |
10705034034805 | K101762 | 000 |
10705034034799 | K101762 | 000 |
10705034034782 | K101762 | 000 |
10705034034904 | K101762 | 000 |
10705034034843 | K101762 | 000 |
10705034034829 | K101762 | 000 |
10705034034867 | K101762 | 000 |
10705034034874 | K101762 | 000 |
10705034034751 | K101762 | 000 |
10705034034959 | K101762 | 000 |
10705034034942 | K101762 | 000 |
10705034034935 | K101762 | 000 |
10705034034928 | K101762 | 000 |
10705034034911 | K101762 | 000 |
10705034034898 | K101762 | 000 |
10705034034881 | K101762 | 000 |
10705034034812 | K101762 | 000 |