RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS— 510(k) K051479

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K051479 for RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS, Substantially Equivalent on 2005-08-10. Applicant: Biomet Manufacturing, Inc..

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2005-06-03
Decision date: 2005-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.