PILONPLATE 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 Pilonplate With Angular Stability.

Pre-market Notification Details

Device IDK052011
510k NumberK052011
Device Name:PILONPLATE 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 Received2005-07-25
Decision Date2005-08-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09120047299814 K052011 000
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09120047290040 K052011 000
09120034303104 K052011 000

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