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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K183054
Device Name SYNMESH System
Applicant
Depuy Synthes Spine
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Michelle Hughes
Correspondent
Depuy Synthes Spine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Michelle Hughes
Regulation Number888.3060
Classification Product Code
MQP  
Date Received11/02/2018
Decision Date 05/23/2019
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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