GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM

Device, Fixation, Proximal Femoral, Implant

EFRATGO, LTD. HI TECH BIO-SURGICAL

The following data is part of a premarket notification filed by Efratgo, Ltd. Hi Tech Bio-surgical with the FDA for Gotfried Percutaneous Compression Plating System.

Pre-market Notification Details

Device IDK983814
510k NumberK983814
Device Name:GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
ClassificationDevice, Fixation, Proximal Femoral, Implant
Applicant EFRATGO, LTD. HI TECH BIO-SURGICAL 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
EFRATGO, LTD. HI TECH BIO-SURGICAL 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
Product CodeJDO  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-28
Decision Date1999-01-14
Summary:summary

NIH GUDID Devices

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