KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD— 510(k) K862057

Substantially Equivalent

Kirschner Medical Corp.

FDA 510(k) clearance K862057 for KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD, Substantially Equivalent on 1986-07-11. Applicant: Kirschner Medical Corp..

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1986-05-30
Decision date: 1986-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

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.