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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 K003971
Device Name AXYA MEDICAL, INC. MODEL 1000 AXYALOOP 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 Codes
GAS   HWC  
Date Received12/22/2000
Decision Date 03/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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