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)— 510(k) K143297

Substantially Equivalent

Zimmer Spine, Inc.

FDA 510(k) clearance K143297 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), Substantially Equivalent on 2015-02-12. Applicant: Zimmer Spine, Inc..

Clearance details

Applicant: Zimmer Spine, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2014-11-17
Decision date: 2015-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.