KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD— 510(k) K862057

Name: FDA 510(k) clearance K862057
Creator: U.S. Food and Drug Administration
Published: 1986-07-11

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.. Device class: 2.

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
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 ↗

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K942891 — SUMMIT TOTAL HIP SYSTEM1994-11-02
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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.