UNIVERSAL DISTAL RADIUS SYSTEM

Plate, Fixation, Bone

NEWCLIP TECHNICS

The following data is part of a premarket notification filed by Newclip Technics with the FDA for Universal Distal Radius System.

Pre-market Notification Details

• Device ID: K130774
• 510k Number: K130774
• Device Name: UNIVERSAL DISTAL RADIUS SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock, TX 78681
• Contact: J.d. Webb
• Correspondent: J.d. Webb; NEWCLIP TECHNICS 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: 2013-03-20
• Decision Date: 2013-06-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700569611903	K130774	000
03700569611774	K130774	000
03700569611767	K130774	000
03700569611750	K130774	000
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03700569626402	K130774	000
03700569612429	K130774	000