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510(k) K113071

SYNTHECEL DURA REPLACEMENT DEVICES by Synthes — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2012
Date Received
October 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dura Substitute
Device Class
Class II
Regulation Number
882.5910
Review Panel
NE
Submission Type

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  • K163456 — DuraGen Secure Dural Regeneration Matrix (January 6, 2017)
  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
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