OLECRANONPLATE 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 Olecranonplate With Angular Stability.

Pre-market Notification Details

Device IDK052368
510k NumberK052368
Device Name:OLECRANONPLATE 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 Received2005-08-29
Decision Date2005-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09120047297001 K052368 000
09120047296981 K052368 000
09120047293836 K052368 000
09120034303029 K052368 000
09120034303012 K052368 000
09120034303005 K052368 000
09120047296998 K052368 000
09120047293843 K052368 000
09120034303036 K052368 000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.