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510(k) K170802

TRAUMACEM™ V+ Injectable Bone Cement by Synthes (USA) Products, LLC — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2017
Date Received
March 17, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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