Cleared Traditional

M2A/C2A ACETABULAR SYSTEM

K042841 · Biomet, Inc. · Orthopedic

Dec 2004

Decision

68d

Days

Class 3

Risk

About This 510(k) Submission

K042841 is an FDA 510(k) clearance for the M2A/C2A ACETABULAR SYSTEM, a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III — Premarket Approval, product code JDL), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 21, 2004, 68 days after receiving the submission on October 14, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3320.

Submission Details

510(k) Number	K042841 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 2004
Decision Date	December 21, 2004
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 888.3320