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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K163486
Device Name DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates
Applicant
Hnm Total Recon, LLC
20855 NE 16th Ave.
Suite C15
Miami,  FL  33179
Applicant Contact Noah Roitman
Correspondent
D2d Development, LLC
1135 W Nasa Blvd.
Melbourne,  FL  32901
Correspondent Contact Craig Pagan
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
HRS   HTY   HWC  
Date Received12/12/2016
Decision Date 07/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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