Cleared Traditional

TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE

K063515 · Biomet Manufacturing, Inc. · Orthopedic

Feb 2007

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K063515 is an FDA 510(k) clearance for the TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE, a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 2, 2007, 73 days after receiving the submission on November 21, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K063515 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2006
Decision Date	February 02, 2007
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3530