CLAVICLE LOCKING PLATE SYSTEM

Plate, Fixation, Bone

NEWCLIP TECHNICS

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

Pre-market Notification Details

Device IDK100944
510k NumberK100944
Device Name:CLAVICLE LOCKING PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
NEWCLIP TECHNICS 1001 OAKWOOD BLVD. Round Rock,  TX  78681
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-06
Decision Date2010-10-22
Summary:summary

NIH GUDID Devices

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