Cleared Traditional

Locking Cage, Full XPE Cup

K163441 · United Orthopedic Corporation · Orthopedic

Aug 2017

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K163441 is an FDA 510(k) clearance for the Locking Cage, Full XPE Cup, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on August 25, 2017, 260 days after receiving the submission on December 8, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K163441 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2016
Decision Date	August 25, 2017
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353