Cleared Traditional

Zimmer Segmental System

K192798 · Zimmer, Inc. · Orthopedic
Dec 2020
Decision
437d
Days
Class 2
Risk

About This 510(k) Submission

K192798 is an FDA 510(k) clearance for the Zimmer Segmental System, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 10, 2020, 437 days after receiving the submission on September 30, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K192798 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2019
Decision Date December 10, 2020
Days to Decision 437 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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