ROCCIA® ACIF— 510(k) K162587

Substantially Equivalent

Silony Medical GmbH

FDA 510(k) clearance K162587 for ROCCIA® ACIF, Substantially Equivalent on 2017-01-26. Applicant: Silony Medical GmbH.

Clearance details

Applicant: Silony Medical GmbH
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2016-09-16
Decision date: 2017-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leinfelden-Echterdingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.