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510(k) K252776

ARIES Anterior Cervical Plate Systems by ZheJiang Decans Medical Devices Co., Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2026
Date Received
September 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by ZheJiang Decans Medical Devices Co., Ltd.

  • K253046 — HERA Interlocking Intramedullary Nailing System (June 16, 2026)
  • K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (June 2, 2026)
  • K253130 — Dione PEEK Screw System (May 27, 2026)
  • K252930 — AQUA Laminoplasty Systems (May 27, 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 KWQ

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  • K260570 — corra™ cervical plating system (April 22, 2026)
  • K260697 — VyPlate™ Anterior Cervical Plate System (March 27, 2026)
  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)