Cleared Traditional

E-CLASS? DUAL MOBILITY INSERTS and DYNASTY? DUAL MOBILITY LINERS

K200011 · Microport Orthopedics, Inc. · Orthopedic
Oct 2021
Decision
638d
Days
Class 2
Risk

About This 510(k) Submission

K200011 is an FDA 510(k) clearance for the E-CLASS? DUAL MOBILITY INSERTS and DYNASTY? DUAL MOBILITY LINERS, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on October 1, 2021, 638 days after receiving the submission on January 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number K200011 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2020
Decision Date October 01, 2021
Days to Decision 638 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3358

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