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510(k) K242895

Aevumed PHANTOM Suture Anchors by Aevumed, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2025
Date Received
September 23, 2024
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 Aevumed, Inc.

  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253040 — Aevumed FASE Suture Anchor (October 21, 2025)
  • K223878 — Aevumed RAPID Suture Anchors (March 17, 2023)
  • K222363 — Aevumed PHANTOM™-LP Suture Anchors (November 28, 2022)
  • K180464 — AEVUMED PHANTOM Suture Anchors (May 31, 2018)

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)