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510(k) K183054

SYNMESH System by Depuy Synthes Spine — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2019
Date Received
November 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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