STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM— 510(k) K052990

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K052990 for STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM, Substantially Equivalent on 2005-12-16. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2005-10-24
Decision date: 2005-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.