Cleared Traditional

INFINITY(TM) MICROTAPER HIP SYSTEM

K913874 · Dow Corning Wright · Orthopedic
Nov 1991
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K913874 is an FDA 510(k) clearance for the INFINITY(TM) MICROTAPER HIP SYSTEM, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on November 27, 1991, 90 days after receiving the submission on August 29, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K913874 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1991
Decision Date November 27, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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