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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K183342
Device Name SambaScrew 3D SI Fusion System
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Applicant Contact Jacki Koch
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Correspondent Contact Jacki Koch
Regulation Number888.3040
Classification Product Code
OUR  
Date Received12/03/2018
Decision Date 04/30/2019
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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