Cleared Traditional

PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT

K001984 · Stelkast Company · Orthopedic
Sep 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K001984 is an FDA 510(k) clearance for the PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT, a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II — Special Controls, product code JDG), submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on September 27, 2000, 90 days after receiving the submission on June 29, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K001984 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2000
Decision Date September 27, 2000
Days to Decision 90 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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