The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Invizia Anterior Certical Plate System, Sc-acufix Ant-cer Dynamic Cervical Plating System, Sc-acufix Slimline Anterior Cervical Plate System, Sc-acufix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica And Trinica.
| Device ID | K143626 |
| 510k Number | K143626 |
| Device Name: | InVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica And Trinica |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439 |
| Contact | Donna M. Semlak |
| Correspondent | Donna M. Semlak Zimmer Spine, Inc. 7375 Bush Lake Road 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 | 2014-12-22 |
| Decision Date | 2015-03-20 |
| Summary: | summary |