Cleared Traditional

THE TAPER-FIT TOTAL HIP SYSTEM

K992234 · Corin USA · Orthopedic
Nov 1999
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K992234 is an FDA 510(k) clearance for the THE TAPER-FIT TOTAL HIP SYSTEM, a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II — Special Controls, product code JDG), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on November 10, 1999, 131 days after receiving the submission on July 2, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K992234 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1999
Decision Date November 10, 1999
Days to Decision 131 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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