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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, fixation, bone
510(k) Number K060970
Device Name AXYALOOP NONABSORBABLE BONE ANCHOR
Applicant
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY,  MA  01915
Applicant Contact Howard Schrayer
Correspondent
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY,  MA  01915
Correspondent Contact Howard Schrayer
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Codes
HWC   MBI  
Date Received04/07/2006
Decision Date 07/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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