Cleared Traditional

Zimmer, Inc. Hip Joint Prostheses MR Labeling I

K200823 · Zimmer, Inc. · Orthopedic
Jul 2020
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K200823 is an FDA 510(k) clearance for the Zimmer, Inc. Hip Joint Prostheses MR Labeling I, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 9, 2020, 101 days after receiving the submission on March 30, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K200823 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2020
Decision Date July 09, 2020
Days to Decision 101 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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