BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    SPINEART SA

    Reg #: 3007728266 · FEI: 3007728266 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    81
    Establishment Types
    2
    Classifications
    47

    Registration Details

    Registration Name
    SPINEART SA
    Registration Number
    3007728266
    FEI Number
    3007728266
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Chemin du Pre-Fleuri 3
    City
    Plan-les-Ouates Geneve
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K081888

    Owner / Operator

    Firm Name
    SPINEART SA
    Operator Number
    10028947
    Address
    Chemin du Pre-Fleuri 3
    City
    Plan-les-Ouates
    State
    Geneve
    Postal Code
    1228
    Country
    CH
    Correspondent
    Max LOK

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Passer, Wire, Orthopedic HXI
    Spinous Process Plate PEK
    Rasp HTR
    Orthopedic Manual Surgical Instrument LXH
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Guide, Surgical, Instrument FZX
    Retractor GAD
    Dissector, Surgical, General & Plastic Surgery GDI
    Bender HXW
    Driver, Prosthesis HWR
    Tap, Bone HWX
    Fork HXE
    Tray, Surgical, Instrument FSM
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Extractor HWB
    Orthopedic Stereotaxic Instrument OLO
    Template HWT
    Posterior Cervical Screw System NKG
    Razor, Surgical LWK
    Probe HXB
    Reamer HTO
    Tape, Measuring, Rulers And Calipers FTY
    Crimper, Pin HXQ
    Elevator, Surgical, General & Plastic Surgery GEG
    Dispenser, Cement KIH
    Wrench HXC
    Forceps, General & Plastic Surgery GEN
    Screwdriver HXX
    Instrument, Compression HWN
    Bone Cement, Posterior Screw Augmentation PML
    Awl HWJ
    Curette, Surgical, General Use FZS
    Bit, Drill HTW
    Instrument, Manual, Surgical, General Use MDM
    Gauge, Depth HTJ
    Osteotome HWM
    Impactor HWA
    Rongeur HTX

    Proprietary Names

    JULIET Cure™ Lumbar Plate System PASSER, WIRE, ORTHOPEDIC (all ranges) CURE ACP 2 ROMEO2PAD JULIET ol RASP (all ranges) Cure OPEL-L Manual surgical instrument (all ranges) JULIET LL-T JULIET Ti Perla TL SCARLET AC-T Tryptik Ti ROMEO SCARLET AL-T Scarlet AL-T Guide, surgical, instrument (all ranges) OTELO retractor DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY (all ranges) BENDER (all ranges) JULIET Ti LL DRIVER, PROSTHESIS (all ranges) Cure OPEL-C ROMEO 2 Bone taps ROMEO2 (multiple) Fork (all ranges) Tray, surgical, instrument (all ranges) JULIET LL lateral Lumbar Cage INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT (all ranges) TRYPTIK2 C-Plate JULIET LL SCARLET AC-T Lordotic version Perla TL MIS TRYPTIK BAGUERA C PERLA TL NAV ROMEO MIS ROMEO LC Talos®-C TEMPLATE (all ranges) PERLA TL CURE™ ACP PERLA RAZOR, SURGICAL (all ranges) PROBE (all ranges) REAMER (all ranges) TAPE, MEASURING, RULERS AND CALIPERS (all ranges) Talos Lumbar CRIMPER, PIN (all ranges) ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY (all ranges) Perla TRYPTIK2 C-plate Talos® Lumbar (HA) PEEK IBF Devices FORCEPS, GENERAL & PLASTIC SURGERY (all ranges) OTELO SCREWDRIVER (all ranges) PERLA NAV ROMEO2 Talos C HA Compression distraction forceps (multiple all ranges) ROMEO LC JULIET LL Ti SCARLET Perla TL MIS NAV Perla TL NAV JULIET PO SCARLET AC-Ti Talos-C (HA) Hyperlordotic Romeo 2 MIS TRYPTIK CA Romeo navigation CURETTE, SURGICAL, GENERAL USE (all ranges) BIT, DRILL (all ranges) Cure LP (IVIEW and QMAX) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (all ranges) GAUGE, DEPTH (all ranges) Talos IBF Talos C Posterior Disc Prep Impactor pusher ( all ranges) RONGEUR (all ranges)

    Establishment Types

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