EPIPHYSIS SCREW

Screw, 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 Epiphysis Screw.

Pre-market Notification Details

Device IDK043410
510k NumberK043410
Device Name:EPIPHYSIS SCREW
ClassificationScrew, 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 CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-10
Decision Date2005-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09120034300875 K043410 000
09120034300783 K043410 000
09120034300790 K043410 000
09120034300813 K043410 000
09120034300837 K043410 000
09120034300844 K043410 000
09120034300851 K043410 000
09120034300882 K043410 000
09120034300899 K043410 000
09120034300905 K043410 000
09120034300912 K043410 000
09120034300806 K043410 000
09120034300820 K043410 000
09120034300868 K043410 000
09120034300776 K043410 000

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