K020045

Substantially Equivalent

3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM

Applicant
Biomet Orthopedics, Inc.
Product code
KWT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Warsaw, IN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KWT

product code KWT
Injury
2,467
Other
2
Total
2,469

Source: openFDA MAUDE database, through . 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.