TAPER-FIT TOTAL HIP SYSTEM— 510(k) K003666

Substantially Equivalent

Corin USA

FDA 510(k) clearance K003666 for TAPER-FIT TOTAL HIP SYSTEM, Substantially Equivalent on 2001-02-08. Applicant: Corin USA.

Clearance details

Applicant
Corin USA
Product code
Code JDI
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tampa, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JDI

product code JDI
Death
65
Injury
12,943
Malfunction
1,681
Total
14,689

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.