AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

Fastener, Fixation, Biodegradable, 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 6500 Axyaloop Bio-absorbable Bone Anchor.

Pre-market Notification Details

Device IDK051250
510k NumberK051250
Device Name:AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
ClassificationFastener, Fixation, Biodegradable, 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 CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-16
Decision Date2005-06-09
Summary:summary

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