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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K163627
Device Name Shotel Ankle Arthrodesis Nail System
Applicant
Biopro, Inc.
2929 Lapeer Rd.
Port Huron,  MI  48060
Applicant Contact Dave Mrak
Correspondent
Convergent Clinical,Inc.
6648 Surf Crest St.
Carlsbad,  CA  92011
Correspondent Contact Al Memmolo
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/22/2016
Decision Date 09/14/2017
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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