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510(k) K133785

TRITIUM STERNAL CABLE PLATE SYSTEM by Pioneer Surgical Technology, Inc. — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2014
Date Received
December 12, 2013
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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  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)
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