BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM

Rod, Fixation, Intramedullary And Accessories

BIODYNAMIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Bti Distal Femoral Intramedullary Rod System.

Pre-market Notification Details

Device IDK970897
510k NumberK970897
Device Name:BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant BIODYNAMIC TECHNOLOGIES, INC. 1425 EAST NEWPORT CENTER DR. Deerfield Beach,  FL  33442
ContactDanny Hodgeman
CorrespondentDanny Hodgeman
BIODYNAMIC TECHNOLOGIES, INC. 1425 EAST NEWPORT CENTER DR. Deerfield Beach,  FL  33442
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-11
Decision Date1997-04-21

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