STERISPINE LC CAGE— 510(k) K133893

Substantially Equivalent

Safe Orthopaedics

FDA 510(k) clearance K133893 for STERISPINE LC CAGE, Substantially Equivalent on 2014-03-14. Applicant: Safe Orthopaedics.

Clearance details

Applicant: Safe Orthopaedics
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2013-12-20
Decision date: 2014-03-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Eragny Sur Oise, FR

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.