INTERBODY CAGE SYSTEM— 510(k) K133967

Substantially Equivalent

Aurora Spine

FDA 510(k) clearance K133967 for INTERBODY CAGE SYSTEM, Substantially Equivalent on 2014-01-31. Applicant: Aurora Spine.

Clearance details

Applicant: Aurora Spine
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2013-12-24
Decision date: 2014-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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.