The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for V2f Anterior Fixation System.
Device ID | K122733 |
510k Number | K122733 |
Device Name: | V2F ANTERIOR FIXATION SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ZIMMER SPINE, INC 5301 RIATA PARK COURT BUILDING F Austin, TX 78727 |
Contact | Jennifer Tribbett |
Correspondent | Jennifer Tribbett ZIMMER SPINE, INC 5301 RIATA PARK COURT BUILDING F Austin, TX 78727 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-06 |
Decision Date | 2012-12-07 |
Summary: | summary |