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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K052491
Device Name AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
Applicant
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY,  MA  01915
Applicant Contact HOWARD L SCHRAYER
Correspondent
AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY,  MA  01915
Correspondent Contact HOWARD L SCHRAYER
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received09/12/2005
Decision Date 10/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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