Alians Elbow Locking Plating System

Plate, Fixation, Bone

NEWCLIP TECHNICS

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

Pre-market Notification Details

• Device ID: K152289
• 510k Number: K152289
• Device Name: Alians Elbow Locking 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-13
• Decision Date: 2016-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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