STERISPINE CC— 510(k) K162531

Substantially Equivalent

Safe Orthopaedics

FDA 510(k) clearance K162531 for STERISPINE CC, Substantially Equivalent on 2016-12-29. Applicant: Safe Orthopaedics.

Clearance details

Applicant: Safe Orthopaedics
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2016-09-09
Decision date: 2016-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eragny Sur Oise, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.