I.T.S. EXTREMITY FIXATION SYSTEMS

Plate, Fixation, Bone

I.T.S. GMBH

The following data is part of a premarket notification filed by I.t.s. Gmbh with the FDA for I.t.s. Extremity Fixation Systems.

Pre-market Notification Details

Device IDK131722
510k NumberK131722
Device Name:I.T.S. EXTREMITY FIXATION SYSTEMS
ClassificationPlate, Fixation, Bone
Applicant I.T.S. GMBH 3150 E. 200TH STREET Prior Lake,  MN  55372
ContactAl Lippincott
CorrespondentAl Lippincott
I.T.S. GMBH 3150 E. 200TH STREET Prior Lake,  MN  55372
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-12
Decision Date2013-08-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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09120034308543 K131722 000

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