Home / 510(k) Clearances / K253027

510(k) K253027

Anchor with Fiber Wire and Disposable Inserter by Ortobio S.A. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2026
Date Received
September 19, 2025
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 for product code MBI

  • K253130 — Dione PEEK Screw System (May 27, 2026)
  • K261363 — Y-Knotless™ Flex Anchors (May 13, 2026)
  • K252635 — ArthroTAK Tendon Anchor Kit (May 1, 2026)
  • K260921 — Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (April 21, 2026)
  • K260561 — Arthrex FiberTak Suture Anchor (March 20, 2026)
  • K253886 — Grappler Suture Anchor PCFD Tether System (March 17, 2026)
  • K254176 — SINEFIX (March 16, 2026)
  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)