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ZheJiang Decans Medical Devices Co., Ltd.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories9
Latest FDA decision2026-06-16
TypeNumberDevice NameCodeDateActions
510(k) K253046 HERA Interlocking Intramedullary Nailing SystemHSB2026-06-16 View
510(k) K253195 TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG2026-06-02 View
510(k) K252930 AQUA Laminoplasty SystemsNQW2026-05-27 View
510(k) K253130 Dione PEEK Screw SystemMBI2026-05-27 View
510(k) K252776 ARIES Anterior Cervical Plate SystemsKWQ2026-05-14 View
510(k) K252542 LEO Spinal SystemNKB2026-04-29 View
510(k) K253213 SAGI Cervical Cage SystemOVE2026-04-20 View
510(k) K252774 Uni-C Cervical Cage SystemOVE2026-04-15 View
510(k) K243665 Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)MBI2025-01-31 View
510(k) K242195 Gemini Cervical Fusion Cage SystemODP2024-11-04 View
510(k) K242267 Gemini Medical Cage SystemMAX2024-10-08 View