Cleared Traditional

VerSys Cemented Revision/Calcar

K210842 · Zimmer, Inc. · Orthopedic
Dec 2021
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K210842 is an FDA 510(k) clearance for the VerSys Cemented Revision/Calcar, 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 December 10, 2021, 263 days after receiving the submission on March 22, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K210842 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2021
Decision Date December 10, 2021
Days to Decision 263 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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