DISTAL RADIUS 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 Distal Radius Locking Plating System.

Pre-market Notification Details

Device IDK061917
510k NumberK061917
Device Name:DISTAL RADIUS LOCKING PLATING 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 Received2006-07-06
Decision Date2006-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03700569613266 K061917 000
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03700569601188 K061917 000

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