BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    NEO MEDICAL S.A.

    Reg #: 3013546462 · FEI: 3013546462 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    71
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    NEO MEDICAL S.A.
    Registration Number
    3013546462
    FEI Number
    3013546462
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Route de Lausanne 157A
    City
    Villette (Lavaux) Vaud
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K212489

    Owner / Operator

    Firm Name
    Neo Medical S.A.
    Operator Number
    10054814
    Address
    Route de Lausanne 157A
    City
    Villette (Lavaux)
    State
    Vaud
    Postal Code
    1096
    Country
    CH

    US Agent

    Business Name
    confinis USA Inc.
    Contact Name
    Alfred Lerch
    Address
    600 Park Offices Drive Suite 300, Unit #50
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    910 2289391

    Products

    Device Name Product Code
    Bone Cement, Posterior Screw Augmentation PML
    Cement, Bone, Vertebroplasty NDN
    Thoracolumbosacral Pedicle Screw System NKB
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Screwdriver HXX
    Bone Cement LOD
    Tap, Bone HWX
    Dispenser, Cement KIH
    Retractor GAD
    Bender HXW
    Light, Surgical, Instrument FSQ
    Orthopedic Manual Surgical Instrument LXH
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Probe HXB
    Tray, Surgical, Instrument FSM

    Proprietary Names

    NEO Pedicle Screw System Neo Cage System Neo Pedicle Screw System Screwdriver Handle, NS Screwdriver Adaptor - 1/4", NS Screwdriver Adaptor - AO, NS Screwdriver Converter - AO, NS Ratchet Handle - 1/4", NS Screwdriver Converter - Hudson, NS Screwdriver Adaptor - Hudson, NS Ratchet Screwdriver ¼”, NS Screwdriver kit Set screwdriver Ratchet Handle - Hudson, NS Set-screwdriver (10x1) Tap kit for Neo Pedicle Screw System Cement Pusher MIS Posterior retractor lateral blade kit 70mm MIS Posterior retractor lateral blade kit 40mm MIS Posterior retractor access kit Lateral retractor kit 180mm Lateral retractor kit 120mm Posterior retractor kit 70mm Posterior retractor access kit Lateral retractor access kit Posterior retractor kit 40mm Posterior retractor kit 50mm Posterior retractor kit 60mm Lateral retractor kit 160mm MIS Posterior retractor kit 80mm Posterior retractor kit 80mm Lateral retractor kit 140mm MIS Posterior retractor lateral blade kit 90mm MIS Posterior retractor lateral blade kit 50mm MIS Posterior retractor lateral blade kit 60mm MIS Posterior retractor lateral blade kit 80mm MIS Posterior retractor kit 70mm MIS Posterior retractor kit 40mm MIS Posterior retractor kit 50mm MIS Posterior retractor kit 60mm Rod Bender NS Neo Flex Light Compressor Distractor Kit Revision Guide (10x1) Ratchet T-Handle - 1/4", NS Cage puller Cage Bent Curette Kit Persuader Non-constraint torque limiter (10x) Cage holder Revision Guide Scraper / distractor Rod Rotation Wrench Cage Instrument Kit Pedicle marker Cage straight curette kit Pedicle Screw Instrument Kit T-Handle Kit Non-constraint torque limiter Posterior instrument kit Cage Pusher Kit Marker Base (10x1) Removal Kit Single Use Pedicle marker (2x) K-wire Kit Screw Guide Remover Sterile container Steffee Complex Set 1 Complex Set 2 Base Set

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device