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510(k) K212197

WasherCap Fixation System by Abanza Tecnomed S.L — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2022
Date Received
July 14, 2021
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 Abanza Tecnomed S.L

  • K253618 — QuadLock™ Fixation System (January 6, 2026)
  • K250238 — WasherCap™ Fixation System (February 25, 2025)
  • K243712 — WasherCap™ Mini Fixation System (Model 45) (January 30, 2025)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • 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)