The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Ardis Interbody System, Bak Interbody Fusion System, Bak/c Anterior Cervical Interbody Fusion System, Infix Anterior Lumbar System, Traxis Vertebral Body Replacement (ti And Vue).
| Device ID | K143297 |
| 510k Number | K143297 |
| Device Name: | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti And VUE) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-17 |
| Decision Date | 2015-02-12 |
| Summary: | summary |