Home / 510(k) Clearances / K250844

510(k) K250844

PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop by Science & Bio Materials (S.B.M.) Sas — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2025
Date Received
March 20, 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 by Science & Bio Materials (S.B.M.) Sas

  • K231787 — ecoFIX® (July 26, 2023)

Other clearances for product code MBI

  • 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)
  • 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)