The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Invizia Anterior Cervical Plate System.
| Device ID | K111796 |
| 510k Number | K111796 |
| Device Name: | INVIZIA ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Contact | Elsa Linke |
| Correspondent | Elsa Linke 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 | 2011-06-27 |
| Decision Date | 2011-10-27 |
| Summary: | summary |