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: K221395
• 510k Number: K221395
• Device Name: Footmotion Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Newclip Technics P.A. De La Lande Saint Martin - 45 Rue Des Garottieres Haute-Goulaine, FR 44 115
• Contact: Gaëlle 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-05-13
• Decision Date: 2022-07-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700569653880	K221395	000
03700569654030	K221395	000
03700569654047	K221395	000
03700569654054	K221395	000
03700569654061	K221395	000
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03700569654085	K221395	000
03700569654092	K221395	000
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03700569654115	K221395	000
03700569654122	K221395	000
03700569654139	K221395	000
03700569654023	K221395	000
03700569654016	K221395	000
03700569654009	K221395	000
03700569653897	K221395	000
03700569653903	K221395	000
03700569653910	K221395	000
03700569653927	K221395	000
03700569653934	K221395	000
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03700569653965	K221395	000
03700569653972	K221395	000
03700569653989	K221395	000
03700569653996	K221395	000
03700569654146	K221395	000
03700569654153	K221395	000
03700569654450	K221395	000
03700569654474	K221395	000
03700569654498	K221395	000
03700569654511	K221395	000
03700569654535	K221395	000
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03700569654658	K221395	000
03700569654672	K221395	000
03700569654436	K221395	000
03700569654412	K221395	000
03700569654283	K221395	000
03700569654160	K221395	000
03700569654177	K221395	000
03700569654184	K221395	000
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03700569654207	K221395	000
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03700569654696	K221395	000