Cleared Special

Volition Plating System

K210658 · Ortho Solutions UK , Ltd. · Orthopedic
Apr 2021
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K210658 is an FDA 510(k) clearance for the Volition Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Ortho Solutions UK , Ltd. (Maldon, GB). The FDA issued a Cleared decision on April 13, 2021, 40 days after receiving the submission on March 4, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K210658 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2021
Decision Date April 13, 2021
Days to Decision 40 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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