OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM— 510(k) K041089

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K041089 for OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM, Substantially Equivalent on 2004-08-31. Applicant: Biomet Manufacturing, Inc..

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2004-04-26
Decision date: 2004-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.