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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K022234
Device Name ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
Applicant
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Applicant Contact ANN WATERHOUSE
Correspondent
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Correspondent Contact ANN WATERHOUSE
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received07/11/2002
Decision Date 10/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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