DeviceClearance

K053293

Substantially Equivalent

ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS

Applicant
Ortho Development Corp.
Product code
LPH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Draper, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LPH

product code LPH
Death
73
Injury
31,640
Malfunction
3,358
Other
2
Total
35,073

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.