BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SILONY MEDICAL GMBH

    Reg #: 3013422236 · FEI: 3013422236 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    75
    Establishment Types
    3
    Classifications
    20

    Registration Details

    Registration Name
    SILONY MEDICAL GMBH
    Registration Number
    3013422236
    FEI Number
    3013422236
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Leinfelder Strasse 60
    City
    Leinfelden-Echterdingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K141942

    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

    US Agent

    Business Name
    RAF SOLUTIONS USA, INC
    Contact Name
    Edwin Lindsay
    Address
    10124 N.W. 53rd Street, Sunrise
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33351
    Country
    US
    Email
    [email protected]
    Phone
    305 9607262

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Screwdriver HXX
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Probe HXB
    Tap, Bone HWX
    Chisel, Surgical, Manual FZO
    Mallet HXL
    Thoracolumbosacral Pedicle Screw System NKB
    Dispenser, Cement KIH
    Tray, Surgical, Instrument FSM
    Orthopedic Manual Surgical Instrument LXH
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Awl HWJ

    Proprietary Names

    MIDLINE II TI VERTICALE Set Screw Starter VERTICALE Screw Driver SPECIALS Set Screw Starter SPECIALS Screw Driver VERTICALE CERVICAL Screw Driver VERTICALE Navigation PCT System ROCCIA PLIF FAVO S-TLIF ROCCIA ACIF STALIF C VERTICALE Probe/Trial Oyster ACIF Trial ROCCIA Probe/Trial VERTICALE CERVICAL Probe/Trial SPECIALS Trial FAVO S-TLIF Trial STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti STALIF TT Tap(s) CERVICAL CAGE Oyster ACIF ROCCIA TLIF ROCCIA ALIF MIDLINE ™ ROCCIA MultiLIF ROCCIA Chisel VERTICALE GPS Instruments STALIF C TI, STALIF C STALIF X Mallet VERTICALE POSTERIOR SPINAL FIXATION SYSTEM OPEN VERTICALE POSTERIOR SPINAL FIXATION SYSTEM MIS VERTICALE Cement Cannula VERTICALE Cement Plunger VERTICALE Cement Delivery Adapter VERTICALE Cement Cleaning Instrument VERTICALE Alignment Cement Adapter VERTICALE Cement Delivery Countertorque Tray, surgical, instrument 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 Drill VERTICALE Cervical Poly screw VERTICALE Cervical Cross Connector VERTICALE Cervical Rod VERTICALE Cervical Occipital Plate VERTICALE Cervical Farangle Screw VERTICALE Cervical Occipital Screw VERTICALE Cervical Set screw VERTICALE Cervical Connector STALIF C; STALIF C-Ti Trifore(TM) Cervical Plating System STALIF(TM) C Awl(s)

    Establishment Types

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