EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES— 510(k) K961719

Substantially Equivalent

Howmedica Leibinger, Inc.

FDA 510(k) clearance K961719 for EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES, Substantially Equivalent on 1997-07-17. Applicant: Howmedica Leibinger, Inc..

Clearance details

Applicant: Howmedica Leibinger, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1996-05-02
Decision date: 1997-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.