FX-CABLELOK SYSTEM

Cerclage, Fixation

BIODYNAMIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Fx-cablelok System.

Pre-market Notification Details

Device IDK912207
510k NumberK912207
Device Name:FX-CABLELOK SYSTEM
ClassificationCerclage, Fixation
Applicant BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington,  VA  22202
ContactAndrew E Taylor
CorrespondentAndrew E Taylor
BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington,  VA  22202
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-20
Decision Date1991-07-09

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