OPTON PRO— 510(k) K141564

Substantially Equivalent

Zimmer Medizinsystems GmbH

FDA 510(k) clearance K141564 for OPTON PRO, Substantially Equivalent on 2014-10-24. Applicant: Zimmer Medizinsystems GmbH.

Clearance details

Applicant: Zimmer Medizinsystems GmbH
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2014-06-12
Decision date: 2014-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neu-Elm, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.