510(k) K992234

THE TAPER-FIT TOTAL HIP SYSTEM by Corin USA — Product Code JDG

K992234 is an FDA 510(k) premarket notification submitted by Corin USA for the device "THE TAPER-FIT TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on November 10, 1999. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Corin USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1999
Date Received
July 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type