DeviceClearance

K191399

Substantially Equivalent

BIOLOX CONTOURA Ceramic Femoral Head

Applicant
Total Joint Othopedics, Inc.
Product code
LZO
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Salt Lake City, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO
Death
17
Injury
12,942
Malfunction
1,756
Total
14,715

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.