HUMERUS 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 Humerus Locking Plating System.

Pre-market Notification Details

• Device ID: K063095
• 510k Number: K063095
• Device Name: HUMERUS LOCKING PLATING 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-10-10
• Decision Date: 2006-12-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700569600839	K063095	000
03700569606411	K063095	000
03700569606435	K063095	000
03700569606459	K063095	000
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03700569617530	K063095	000