Cleared Traditional

DUAL LOCK HIP STEM

K980794 · Depuy, Inc. · Orthopedic
May 1998
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K980794 is an FDA 510(k) clearance for the DUAL LOCK HIP STEM, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 20, 1998, 79 days after receiving the submission on March 2, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K980794 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1998
Decision Date May 20, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

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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