Cleared Traditional

K112794 - EOS SMALL BONE FIXATION SYSTEM
(FDA 510(k) Clearance)

K112794 · TriMed, Inc. · Orthopedic

May 2012

Decision

227d

Days

Class 2

Risk

K112794 is an FDA 510(k) clearance for the EOS SMALL BONE FIXATION SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by TriMed, Inc. (Valencia, US). The FDA issued a Cleared decision on May 10, 2012, 227 days after receiving the submission on September 26, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K112794 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2011
Decision Date	May 10, 2012
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF