Cleared Traditional

K112509 - TRIMED CLAVICLE FIXATION SYSTEM
(FDA 510(k) Clearance)

K112509 · TriMed, Inc. · Orthopedic

Nov 2011

Decision

66d

Days

Class 2

Risk

K112509 is an FDA 510(k) clearance for the TRIMED CLAVICLE 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 November 4, 2011, 66 days after receiving the submission on August 30, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K112509 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2011
Decision Date	November 04, 2011
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF