AXYALOOP NONABSORBABLE BONE ANCHOR

Staple, Fixation, Bone

AXYA MEDICAL, INC.

The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axyaloop Nonabsorbable Bone Anchor.

Pre-market Notification Details

Device IDK060970
510k NumberK060970
Device Name:AXYALOOP NONABSORBABLE BONE ANCHOR
ClassificationStaple, Fixation, Bone
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 CodeJDR  
Subsequent Product CodeHWC
Subsequent Product CodeMBI
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-07
Decision Date2006-07-05
Summary:summary

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