Cleared Traditional

OR3O Dual Mobility Liners

K232667 · Smith & Nephew, Inc. · Orthopedic
Oct 2023
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K232667 is an FDA 510(k) clearance for the OR3O Dual Mobility Liners, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on October 27, 2023, 56 days after receiving the submission on September 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number K232667 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2023
Decision Date October 27, 2023
Days to Decision 56 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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