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510(k) K131792

SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY by Synthes, Inc. — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2013
Date Received
June 18, 2013
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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  • K122647 — SYNTHES PATIENT SPECIFIC PLATE (February 28, 2013)

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  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
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