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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K014155
Device Name OPENING/CLOSING WEDGE OSTETOMY PLATES
Applicant
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Applicant Contact ANN WATERHOUSE
Correspondent
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Correspondent Contact ANN WATERHOUSE
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/19/2001
Decision Date 03/18/2002
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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