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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 K181067
Device Name AlignX Ankle Fusion System
Applicant
Extremity Medical, LLC
300 Interpace Pkwy.
Suite 410
Parsippany,  NJ  07054
Applicant Contact Brian Smekal
Correspondent
Extremity Medical, LLC
300 Interpace Pkwy.
Suite 410
Parsippany,  NJ  07054
Correspondent Contact Brian Smekal
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/23/2018
Decision Date 05/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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