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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 K161058
Device Name Cannulated Screw
Applicant
Miami Device Solutions, LLC
7620 NW 25th St., Unit 3
Miami,  FL  33122
Applicant Contact MARKKU BIEDERMANN
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-Llle-Perrot,  CA J7V7P2
Correspondent Contact ROBERT POGGIE
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received04/15/2016
Decision Date 07/29/2016
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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