The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Virage Oct Spinal Fixation System.
Device ID | K133556 |
510k Number | K133556 |
Device Name: | VIRAGE OCT SPINAL FIXATION SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
Contact | Holly Seppanen |
Correspondent | Holly Seppanen ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-19 |
Decision Date | 2014-06-02 |
Summary: | summary |