Cleared Traditional

PolyLock Small Bone Plating System

K192323 · Fusion Orthopedics, LLC · Orthopedic
Nov 2019
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K192323 is an FDA 510(k) clearance for the PolyLock Small Bone Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Fusion Orthopedics, LLC (Mesa, US). The FDA issued a Cleared decision on November 18, 2019, 83 days after receiving the submission on August 27, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K192323 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2019
Decision Date November 18, 2019
Days to Decision 83 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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