VOLAR RADIUS PLATE WITH ANGULAR STABILITY

Plate, Fixation, Bone

I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH

The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for Volar Radius Plate With Angular Stability.

Pre-market Notification Details

Device IDK033756
510k NumberK033756
Device Name:VOLAR RADIUS PLATE WITH ANGULAR STABILITY
ClassificationPlate, Fixation, Bone
Applicant I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake,  MN  55372
ContactAl Lippincott
CorrespondentAl Lippincott
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake,  MN  55372
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-01
Decision Date2004-02-06
Summary:summary

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