Cleared Traditional

MAESTRO WRIST FRACTURE IMPLANT

K080426 · Biomet Manufacturing Corp · Orthopedic

Jul 2008

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K080426 is an FDA 510(k) clearance for the MAESTRO WRIST FRACTURE IMPLANT, a Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (Class II — Special Controls, product code JWJ), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on July 29, 2008, 160 days after receiving the submission on February 20, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3800.

Submission Details

510(k) Number	K080426 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 2008
Decision Date	July 29, 2008
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWJ — Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3800