Cleared Traditional

UTF Stem, reduced, #0, #00

K163193 · United Orthopedic Corporation · Orthopedic

Jun 2017

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K163193 is an FDA 510(k) clearance for the UTF Stem, reduced, #0, #00, 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 June 8, 2017, 205 days after receiving the submission on November 15, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K163193 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 2016
Decision Date	June 08, 2017
Days to Decision	205 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