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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, biodegradable, soft tissue
510(k) Number K051983
Device Name MODEL 3000 AXYALOOP BIO-ABSORBABLE 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
MAI  
Date Received07/22/2005
Decision Date 08/05/2005
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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