Cleared Traditional

Ortho Solutions Plating System

K202764 · Ortho Solutions UK , Ltd. · Orthopedic
Nov 2020
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K202764 is an FDA 510(k) clearance for the Ortho Solutions 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 November 20, 2020, 60 days after receiving the submission on September 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K202764 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2020
Decision Date November 20, 2020
Days to Decision 60 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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