Cleared Traditional

MAESTRO CARPAL HEMIARTHROPLASTY

K050028 · Biomet Manufacturing, Inc. · Orthopedic

Mar 2005

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K050028 is an FDA 510(k) clearance for the MAESTRO CARPAL HEMIARTHROPLASTY, a Prosthesis, Wrist, Carpal Lunate (Class II — Special Controls, product code KWN), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 25, 2005, 78 days after receiving the submission on January 6, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3750.

Submission Details

510(k) Number	K050028 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2005
Decision Date	March 25, 2005
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF