Cleared Traditional

PPC HIP STEM COMPONENT

K915385 · Implantology Corp. · Orthopedic
May 1993
Decision
535d
Days
Class 2
Risk

About This 510(k) Submission

K915385 is an FDA 510(k) clearance for the PPC 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 May 17, 1993, 535 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 K915385 FDA.gov
FDA Decision Cleared SN
Date Received November 29, 1991
Decision Date May 17, 1993
Days to Decision 535 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

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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