Cleared Traditional

TANDEM Hip System

K231448 · Smith & Nephew, Inc. · Orthopedic
Jul 2023
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K231448 is an FDA 510(k) clearance for the TANDEM Hip System, a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II — Special Controls, product code LZY), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on July 19, 2023, 62 days after receiving the submission on May 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K231448 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2023
Decision Date July 19, 2023
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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