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510(k) K120600

DURAGEN SECURE DURAL REGNERATION MATRIX by Integra Life Sciences — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2012
Date Received
February 28, 2012
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

Other clearances by Integra Life Sciences

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  • K212943 — SyntheCel Dura Repair (January 28, 2022)
  • K183513 — XenoSure Dura Biologic Patch (June 13, 2019)
  • K172603 — Cerafix Dura Substitute (November 27, 2017)
  • K163456 — DuraGen Secure Dural Regeneration Matrix (January 6, 2017)
  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
  • K161278 — Cerafix Dura Substitute (August 8, 2016)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)