MOORE HIP PROSTHESIS, PMMA COATED— 510(k) K811416

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K811416 for MOORE HIP PROSTHESIS, PMMA COATED, Substantially Equivalent on 1981-08-12. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1981-05-19
Decision date: 1981-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.