Fitmore Hip Stem— 510(k) K192236

Substantially Equivalent

Zimmer GmbH

FDA 510(k) clearance K192236 for Fitmore Hip Stem, Substantially Equivalent on 2019-11-05. Applicant: Zimmer GmbH.

Clearance details

Applicant: Zimmer GmbH
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2019-08-19
Decision date: 2019-11-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Winterthur, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.