The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Optio-c Anterior Cervical System.
| Device ID | K132894 |
| 510k Number | K132894 |
| Device Name: | OPTIO-C ANTERIOR CERVICAL SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Contact | Donna Semlak |
| Correspondent | Donna Semlak ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-16 |
| Decision Date | 2014-01-16 |
| Summary: | summary |