STERISPINE PS Pedicle Screw— 510(k) K150092

Substantially Equivalent

Safe Orthopaedics

FDA 510(k) clearance K150092 for STERISPINE PS Pedicle Screw, Substantially Equivalent on 2015-02-10. Applicant: Safe Orthopaedics.

Clearance details

Applicant: Safe Orthopaedics
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2015-01-16
Decision date: 2015-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Eragny Sur Oise, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.