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 | K141500 |
| 510k Number | K141500 |
| Device Name: | OPTIO-C ANTERIOR CERVICAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ZIMMER SPINE, INC. 7375 Bush Lake Rd Minneapolis, MN 55439 |
| Contact | Donna M Semlak |
| Correspondent | Donna M Semlak ZIMMER SPINE, INC. 7375 Bush Lake Rd Minneapolis, MN 55439 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-06 |
| Decision Date | 2014-09-23 |
| Summary: | summary |