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    FDA Registration Active 🇺🇸 United States

    Silony Spine Corporation

    Reg #: 3013422238 · FEI: 3013422238 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    36
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    Silony Spine Corporation
    Registration Number
    3013422238
    FEI Number
    3013422238
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8200 NW 27th Street, Suite #104
    City
    Doral
    State
    FL
    ZIP
    33122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173347

    Owner / Operator

    Firm Name
    Silony Medical GmbH
    Operator Number
    10054311
    Address
    Leinfelder Strasse 60
    City
    Leinfelden-Echterdingen
    State
    Baden-Wurttemberg
    Postal Code
    70771
    Country
    DE

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Orthopedic Manual Surgical Instrument LXH
    Spinal Vertebral Body Replacement Device MQP
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    MIDLINE ™ STALIF C STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti STALIF TT CERVICAL CAGE Working Tower Frames Shaver Pusher Control Gauges Forceps Scraper Handle Adapter Loading Block (Re-)Positioning Tools Drill Guide Guiding instruments Distractor Inserter Dilatator Torque Limiter Counter Torque Implant modifier Orthopedic manual surgical instrument Paddle Sizer STALIF(TM) C STALIF MIDLINE STALIF X STALIF C TI, STALIF C MIDLINE II TI STALIF C; STALIF C-Ti STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM VERTICALE GPS Instruments PCT System Trifore(TM) Cervical Plating System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility