Cleared Traditional

SMOOTH OR THREADED METALLIC BONE FASTENER

K131640 · Biomedical Ent., Inc. · Orthopedic

Oct 2013

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K131640 is an FDA 510(k) clearance for the SMOOTH OR THREADED METALLIC BONE FASTENER, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on October 16, 2013, 134 days after receiving the submission on June 4, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K131640 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2013
Decision Date	October 16, 2013
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF