K052685

Substantially Equivalent

ORTHOPEDIC SALVAGE SYSTEM- OSS

Applicant: Biomet, Inc.
Product code: KRO
Advisory panel: Orthopedic
Date received: 2005-09-28
Decision date: 2005-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

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.