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510(k) K110789

SYNTHES STERNAL ZIPFIX SYSTEM by Synthes (Usa) — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2011
Date Received
March 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

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