Cleared Traditional

Conformity Stem

K183312 · United Orthopedic Corporation · Orthopedic

Aug 2019

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K183312 is an FDA 510(k) clearance for the Conformity Stem, 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 City, TW). The FDA issued a Cleared decision on August 8, 2019, 252 days after receiving the submission on November 29, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K183312 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2018
Decision Date	August 08, 2019
Days to Decision	252 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