HOWMEDICA THREADED ACETABULAR COMPONENT— 510(k) K850840

Substantially Equivalent

Pfizer, Inc.

FDA 510(k) clearance K850840 for HOWMEDICA THREADED ACETABULAR COMPONENT, Substantially Equivalent on 1985-07-15. Applicant: Pfizer, Inc..

Clearance details

Applicant: Pfizer, Inc.
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 1985-03-01
Decision date: 1985-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ny, NY, US

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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.