AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

AXYA MEDICAL, INC.

The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axya, Model 3000 Axyzloop Titanium Bone Anchor.

Pre-market Notification Details

Device IDK070773
510k NumberK070773
Device Name:AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
ContactHoward L Schrayer
CorrespondentHoward L Schrayer
AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
Product CodeMBI  
Subsequent Product CodeHWC
Subsequent Product CodeJDR
Subsequent Product CodeMAI
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-21
Decision Date2007-10-11
Summary:summary

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