Cleared Traditional

K012469 - RESORBABLE NO PROFILE SCREW AND WASHER
(FDA 510(k) Clearance)

K012469 · Biomet Manufacturing, Inc. · Orthopedic

Dec 2001

Decision

123d

Days

Class 2

Risk

K012469 is an FDA 510(k) clearance for the RESORBABLE NO PROFILE SCREW AND WASHER, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 3, 2001, 123 days after receiving the submission on August 2, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K012469 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2001
Decision Date	December 03, 2001
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF