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510(k) K253130

Dione PEEK Screw System by ZheJiang Decans Medical Devices Co., Ltd. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2026
Date Received
September 25, 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 ZheJiang Decans Medical Devices Co., Ltd.

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  • K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (June 2, 2026)
  • K252930 — AQUA Laminoplasty Systems (May 27, 2026)
  • K252776 — ARIES Anterior Cervical Plate Systems (May 14, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253213 — SAGI Cervical Cage System (April 20, 2026)
  • K252774 — Uni-C Cervical Cage System (April 15, 2026)
  • K243665 — Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor Sy (January 31, 2025)
  • K242195 — Gemini Cervical Fusion Cage System (November 4, 2024)
  • K242267 — Gemini Medical Cage System (October 8, 2024)

Other clearances for product code MBI

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  • 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)