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510(k) K063117

MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX by Medtronic Neurosurgery — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2006
Date Received
October 12, 2006
Clearance Type
Special
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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  • 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)