Stern Fix Sternal Stabilization System— 510(k) K211613

Substantially Equivalent

Neos Surgery S.L

FDA 510(k) clearance K211613 for Stern Fix Sternal Stabilization System, Substantially Equivalent on 2022-01-19. Applicant: Neos Surgery S.L.

Clearance details

Applicant: Neos Surgery S.L
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 2021-05-26
Decision date: 2022-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.