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510(k) K240835

Suture Button Repair System by Skeletal Dynamics, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2024
Date Received
March 26, 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

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  • K242055 — Freefix Forearm Plating System (August 1, 2024)
  • K233574 — Total Wrist Arthroplasty System (TWA) (July 3, 2024)
  • K231447 — Double Internal Joint Stabilizer- Elbow (December 15, 2023)
  • K231188 — ALIGN Radial Head System (September 28, 2023)
  • K231623 — Distal Elbow Plating System (August 28, 2023)
  • K223318 — Internal Joint Stabilizer - Elbow (May 10, 2023)

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)