AXYA MEDICAL, INC. MODEL 5000 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 Medical, Inc. Model 5000 Axyaloop Bio-absorbable Bone Anchor.

Pre-market Notification Details

Device IDK041698
510k NumberK041698
Device Name:AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
ContactHoward Schrayer
CorrespondentHoward Schrayer
AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly,  MA  01915
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-22
Decision Date2004-10-05
Summary:summary

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