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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 K161371
Device Name Sonoma Fifth Metatarsal Repair System
Applicant
Sonoma Orthopedic Products, Inc.
1388 Busch Pkwy.
Buffalo Grove,  IL  60089
Applicant Contact Rick Epstein
Correspondent
Mrc-X, LLC
6075 Poplar Ave., Suite 500
Memphis,  TN  38119
Correspondent Contact Dawn Norman
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/17/2016
Decision Date 02/24/2017
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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