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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 K160069
Device Name Sonoma Fibula Repair System
Applicant
Sonoma Orthopedics Products, Inc.
1388 Busch Pkwy.
Buffalo Grove,  IL  60089
Applicant Contact Rick Epstein
Correspondent
Memphis Regulatory Consulting, LLC
3416 Roxee Run Cove
Bartlett,  TN  38133
Correspondent Contact Dawn Norman
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/13/2016
Decision Date 03/10/2016
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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