IDYS LIF CAGES— 510(k) K131178

Substantially Equivalent

Clariance

FDA 510(k) clearance K131178 for IDYS LIF CAGES, Substantially Equivalent on 2013-10-10. Applicant: Clariance.

Clearance details

Applicant: Clariance
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2013-04-25
Decision date: 2013-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philedelphia, PA, 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.