HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS— 510(k) K951115

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K951115 for HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS, Substantially Equivalent on 1995-06-16. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 1995-03-10
Decision date: 1995-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.