DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT— 510(k) K945613

Name: FDA 510(k) clearance K945613
Creator: U.S. Food and Drug Administration
Published: 1995-03-06

Substantially Equivalent for Some Indications

Howmedica Corp.

FDA 510(k) clearance K945613 for DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT, Substantially Equivalent for Some Indications on 1995-03-06. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 1994-11-15
Decision date: 1995-03-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.