DISTAL HUMERAL PLATES 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 Distal Humeral Plates With Angular Stability.

Pre-market Notification Details

Device IDK080184
510k NumberK080184
Device Name:DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
ClassificationPlate, Fixation, Bone
Applicant I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake,  MN  55372
ContactAl Lippinocott
CorrespondentAl Lippinocott
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 Received2008-01-25
Decision Date2008-03-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09120034305337 K080184 000
09120034305245 K080184 000
09120034305252 K080184 000
09120034305283 K080184 000
09120034305290 K080184 000
09120034305306 K080184 000
09120034305313 K080184 000
09120034304910 K080184 000
09120034304927 K080184 000
09120034304934 K080184 000
09120034305269 K080184 000
09120034305276 K080184 000
09120034305320 K080184 000
09120034304903 K080184 000

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