Footmotion Plating System

Plate, Fixation, Bone

Newclip Technics

The following data is part of a premarket notification filed by Newclip Technics with the FDA for Footmotion Plating System.

Pre-market Notification Details

• Device ID: K171510
• 510k Number: K171510
• Device Name: Footmotion Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Newclip Technics PA De La Lande Saint Martin - 45 Rue Des Garottieres Haute-goulaine, FR 44 115
• Contact: Gaelle Lussori
• Correspondent: J.d. Webb; The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-24
• Decision Date: 2017-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700569610593	K171510	000
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03700569636234	K171510	000
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03700569655099	K171510	000