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510(k) K181086

Cortical Fixation Systems by Cousin Biotech Sas — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2019
Date Received
April 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Cousin Biotech Sas

  • K181799 — ResCUBE™ Ligament Fixation System (August 29, 2018)
  • K172206 — NAJA™ Ligament Correction System (April 10, 2018)
  • K133889 — PREMIUM (September 4, 2014)
  • K093196 — BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 (June 25, 2010)
  • K072962 — CABS'AIR (June 26, 2008)
  • K070918 — 4DDOME (August 22, 2007)

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  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)