CoLink NeoFuse 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 Neofuse Plating System.

Pre-market Notification Details

• Device ID: K213069
• 510k Number: K213069
• Device Name: CoLink NeoFuse 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: 2021-09-23
• Decision Date: 2021-12-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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