Cleared Traditional

CoLink View Plating System

K172300 · In2bones USA, LLC · Orthopedic
Nov 2017
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K172300 is an FDA 510(k) clearance for the CoLink View Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on November 27, 2017, 119 days after receiving the submission on July 31, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K172300 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2017
Decision Date November 27, 2017
Days to Decision 119 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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