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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 K171018
Device Name Axis Charcot Fixation System, 4.5 to 8.5mm Screw 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 Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received04/05/2017
Decision Date 07/13/2017
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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