Cleared Traditional

U2 Bipolar Implant and 22mm Femoral Head

K152439 · United Orthopedic Corporation · Orthopedic

Apr 2016

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K152439 is an FDA 510(k) clearance for the U2 Bipolar Implant and 22mm Femoral Head, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on April 7, 2016, 224 days after receiving the submission on August 27, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K152439 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2015
Decision Date	April 07, 2016
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390