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510(k) K110604

VBB SYSTEM by Synthes — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2011
Date Received
March 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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