Cleared Special

36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT

K070061 · Hayes Medical, Inc. · Orthopedic

Jan 2007

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K070061 is an FDA 510(k) clearance for the 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code LWJ), submitted by Hayes Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on January 31, 2007, 26 days after receiving the submission on January 5, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number	K070061 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2007
Decision Date	January 31, 2007
Days to Decision	26 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LWJ — Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3360