Cleared Special

OsteoMed ExtremiLOCK Wrist Plating System

K161041 · Osteomed · Orthopedic
May 2016
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K161041 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 May 19, 2016, 36 days after receiving the submission on April 13, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K161041 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2016
Decision Date May 19, 2016
Days to Decision 36 days
Submission Type Special
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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