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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K150673
Device Name SYNFIX Evolution Secured Spacer System
Applicant
Synthes (USA) Products, LLC
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact EUGENE BANG
Correspondent
Synthes (USA) Products, LLC
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact EUGENE BANG
Regulation Number888.3080
Classification Product Code
OVD  
Date Received03/16/2015
Decision Date 08/21/2015
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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