ARROW-LOK DIGITAL SYSTEM

Pin, Fixation, Smooth

ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC

The following data is part of a premarket notification filed by Arrowhead Medical Device Technologies Llc with the FDA for Arrow-lok Digital System.

Pre-market Notification Details

Device IDK112675
510k NumberK112675
Device Name:ARROW-LOK DIGITAL SYSTEM
ClassificationPin, Fixation, Smooth
Applicant ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC 328 POPLAR VIEW LANE EAST SUITE 2 Collierville,  TN  38017
ContactThomas J Twardzik
CorrespondentThomas J Twardzik
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC 328 POPLAR VIEW LANE EAST SUITE 2 Collierville,  TN  38017
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-14
Decision Date2011-12-12
Summary:summary

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