Cleared Traditional

EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM

K062775 · Ortho Development Corp. · Orthopedic

Jan 2007

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K062775 is an FDA 510(k) clearance for the EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on January 16, 2007, 120 days after receiving the submission on September 18, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K062775 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2006
Decision Date	January 16, 2007
Days to Decision	120 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