Cleared Traditional

U2 Femoral Head

K162957 · United Orthopedic Corporation · Orthopedic

Jul 2017

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K162957 is an FDA 510(k) clearance for the U2 Femoral Head, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on July 17, 2017, 266 days after receiving the submission on October 24, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K162957 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2016
Decision Date	July 17, 2017
Days to Decision	266 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