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 |