BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENESYS SPINE

    Reg #: 3008455034 · FEI: 3008455034 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    40
    Establishment Types
    2
    Classifications
    26

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    Registration Details

    Registration Name
    GENESYS SPINE
    Registration Number
    3008455034
    FEI Number
    3008455034
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1250 S Capital of TX Highway, Building Three, Suite 600
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233594

    Owner / Operator

    Firm Name
    Genesys Spine
    Operator Number
    10033848
    Address
    1250 Capital of Texas Highway South, Building Three, Suite 600
    City
    Austin
    State
    TX
    Postal Code
    78746
    Country
    US
    Correspondent
    William W Sowers

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Orthopedic Stereotaxic Instrument OLO
    Sacroiliac Joint Fixation OUR
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Awl HWJ
    Probe HXB
    Extractor HWB
    Orthopedic Manual Surgical Instrument LXH
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Interlaminal KWP
    Passer, Wire, Orthopedic HXI
    Rongeur HTX
    Mallet HXL
    Pliers, Surgical HTC
    Screwdriver HXX
    Template HWT
    Tap, Bone HWX
    Cutter, Wire HXZ
    Wrench HXC
    Caliper KTZ
    Bender HXW

    Proprietary Names

    Stasys-C Standalone 3DP TiLock Stasys-C Standalone PEEK SIros-X System Binary Anterior Cervical Plate System Apache Anchored Cervical Interbody Fusion System Genesys Spine Sacroiliac Joint Fusion System Genesys Spine Anterior Cervical Plate System Apache Interbody Fusion System Apache IBFD / VBR Apache Interbody System Apache Cervical Stand-Alone System AIS-C Stand-Alone System Genesys Spine AIS-C Cervical Stand-Alone System AIS-C Apache Genesys Spine Anterior Buttress Plate System Apache Lumbar IBFD System TiLock2 Spinal System SIros-O Sacroiliac Joint Fusion System SIros Sacroiliac Joint Fusion System with Navigation SIros-O Sacroiliac Joint Fusion System with Navigation SIros Sacroiliac Joint Fusion System Genesys Spine Rongeur TiLock Cortical Spinal System Binary Lumbar Plate System AIS-C Cervical Anchored Interbody System Binary Anterior Cervical Plate System with Helios Technology TiLock Modular Spinal System Genesys Cervical Plate with Helios Technology TiLock Pedicle Screw System Binary Apache IBFD Star Cervical System Genesys Spine 3DP Lumbar Interbody System Apache Hyperlordotic ALIF Genesys Spine Binary® Lumbar Plate System Intervertebral Fusion Device with Bone Graft, Lumbar Apache Milled Titanium IBFD Genesys Spine 3DP Cervical Interbody System Luna 360

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility