Cleared Traditional

OsteoMed ExtremiLOCK Wrist Plating System

K152145 · Osteomed · Orthopedic
Dec 2015
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K152145 is an FDA 510(k) clearance for the OsteoMed ExtremiLOCK Wrist Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on December 21, 2015, 140 days after receiving the submission on August 3, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K152145 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2015
Decision Date December 21, 2015
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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