The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Zimmer Virage Oct Spinal Fixation System.
| Device ID | K153631 |
| 510k Number | K153631 |
| Device Name: | Zimmer Virage OCT Spinal Fixation System |
| Classification | Posterior Cervical Screw System |
| Applicant | Zimmer Spine, Inc 7375 Bush Lake Road Minneapolis, MN 55439 |
| Contact | Ted Kuhn |
| Correspondent | Ted Kuhn Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-18 |
| Decision Date | 2016-02-16 |
| Summary: | summary |