Cleared Traditional

FPC HIP STEM COMPONENT

K915391 · Implantology Corp. · Orthopedic
Apr 1993
Decision
518d
Days
Class 2
Risk

About This 510(k) Submission

K915391 is an FDA 510(k) clearance for the FPC HIP STEM COMPONENT, a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II — Special Controls, product code JDG), submitted by Implantology Corp. (Pine Brook, US). The FDA issued a Cleared decision on April 30, 1993, 518 days after receiving the submission on November 29, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K915391 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1991
Decision Date April 30, 1993
Days to Decision 518 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

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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