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 | K151031 |
| 510k Number | K151031 |
| Device Name: | Virage OCT Spinal Fixation System |
| Classification | Posterior Cervical Screw System |
| Applicant | ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Contact | Donna M. Semlak |
| Correspondent | Jonathan Gilbert ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-17 |
| Decision Date | 2015-06-24 |
| Summary: | summary |