BEUDAMED
    FDA Registration Active 🇫🇷 France

    ALPES CN SAS

    Reg #: 3037407500 · FEI: 3037407500 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    81
    Establishment Types
    3
    Classifications
    47

    Registration Details

    Registration Name
    ALPES CN SAS
    Registration Number
    3037407500
    FEI Number
    3037407500
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    356 Rue de la Tour
    City
    Reignier-Esery Haute-Savoie
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K151104

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

    Proprietary Names

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

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device