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510(k) K223445

ArtiFascia by Nurami Medical , Ltd. — Product Code GXQ

K223445 is an FDA 510(k) premarket notification submitted by Nurami Medical , Ltd. for the device "ArtiFascia". The FDA issued a decision of Substantially Equivalent on August 10, 2023. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2023
Date Received
November 14, 2022
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 for product code GXQ

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  • K250420 — Helios Dura Regeneration Matrix (May 14, 2025)
  • 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)
  • K150825 — Collagen Dural Regeneration Matrix (November 20, 2015)

FDA data resources