Cleared Traditional

ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS

K060577 · Ortho Development Corp. · Orthopedic

Apr 2006

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K060577 is an FDA 510(k) clearance for the ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on April 28, 2006, 53 days after receiving the submission on March 6, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K060577 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2006
Decision Date	April 28, 2006
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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