AXYA MODEL 6500 AXYALOOP SELF-TAPPING 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 6500 Axyaloop Self-tapping Bone Anchor.

Pre-market Notification Details

Device IDK052491
510k NumberK052491
Device Name:AXYA MODEL 6500 AXYALOOP SELF-TAPPING 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  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-12
Decision Date2005-10-07
Summary:summary

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