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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K172205
Device Name ExoToe Staple
Applicant
Exotoe, LLC
P.O. Box 548
Grimes,  IA  50111
Applicant Contact Avi Roop
Correspondent
Edgeone Medical
455 N Campbell Ave.
Suite #2n
Chicago,  IL  60612
Correspondent Contact Jerzy Wojcik
Regulation Number888.3030
Classification Product Code
JDR  
Date Received07/21/2017
Decision Date 01/11/2018
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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