BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Gemini Cervical Fusion Cage System

    K Number: K242195 · Decision Nov 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    11
    Review Days
    101

    Basic Information

    Device Name
    Gemini Cervical Fusion Cage System
    K Number
    K242195
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ZheJiang Decans Medical Devices Co., Ltd.
    Date Received
    July 26, 2024
    Decision Date
    November 4, 2024
    Product Code
    ODP
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ODP), ordered by most recent decision date.

    BluEX Cervical Expandable Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTEOMNI SPINAL CAGES SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORIO-3D Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MOD-C

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

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

    K Number Device Name
    K253046 HERA Interlocking Intramedullary Nailing System
    K253195 TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
    K253130 Dione PEEK Screw System
    K252930 AQUA Laminoplasty Systems
    K252776 ARIES Anterior Cervical Plate Systems
    K252542 LEO Spinal System
    K253213 SAGI Cervical Cage System
    K252774 Uni-C Cervical Cage System
    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)
    K242267 Gemini Medical Cage System
    Search all 11 clearances from ZheJiang Decans Medical Devices Co., Ltd. →