Cleared Special

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System

K193543 · In2bones USA, LLC · Orthopedic

Jan 2020

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K193543 is an FDA 510(k) clearance for the CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx 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 January 17, 2020, 28 days after receiving the submission on December 20, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K193543 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2019
Decision Date	January 17, 2020
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF