CoLink Cfx Plating System

Plate, Fixation, Bone

In2Bones USA, LLC

The following data is part of a premarket notification filed by In2bones Usa, Llc with the FDA for Colink Cfx Plating System.

Pre-market Notification Details

• Device ID: K200762
• 510k Number: K200762
• Device Name: CoLink Cfx Plating System
• Classification: Plate, Fixation, Bone
• Applicant: In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis, TN 38119
• Contact: Christine Scifert
• Correspondent: Christine Scifert; In2Bones USA, LLC 6000 Poplar Ave. Suite 115 Memphis, TN 38119
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-24
• Decision Date: 2020-04-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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