Cleared Traditional

Libertas Hip Replacement System

K180973 · Maxx Orthopedics, Inc. · Orthopedic
Sep 2018
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K180973 is an FDA 510(k) clearance for the Libertas Hip Replacement System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Maxx Orthopedics, Inc. (Plymouth Meeting, US). The FDA issued a Cleared decision on September 28, 2018, 168 days after receiving the submission on April 13, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K180973 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2018
Decision Date September 28, 2018
Days to Decision 168 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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