BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Choice Spine LLC

    Reg #: 3005819474 · FEI: 3005819474 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    99
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    Choice Spine LLC
    Registration Number
    3005819474
    FEI Number
    3005819474
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    400 Erin Dr
    City
    Knoxville
    State
    TN
    ZIP
    37919
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030252

    Owner / Operator

    Firm Name
    CHOICE SPINE, LLC
    Operator Number
    9090881
    Address
    400 ERIN DRIVE
    City
    Knoxville
    State
    TN
    Postal Code
    37919
    Country
    US
    Correspondent
    Kim - Finch

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Filler, Bone Void, Calcium Compound MQV
    Posterior Cervical Screw System NKG
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    System, Facet Screw Spinal Device MRW
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Orthopedic Manual Surgical Instrument LXH
    Screwdriver HXX
    Sacroiliac Joint Fixation OUR
    Tap, Bone HWX

    Proprietary Names

    ORIA SCS Extended Omniaxial Conn. Thunderbolt & Lancer Open Pedicle Screw System Ascendant PC Octance Straight PC Choice Spine TiGer Shark System Stratofuse BA Thunderbolt & Lancer Open Pedicle screw System Gilbralt Blackhawk Cervical Spacer System Tomcat Cervical Spinal System Blackhawk Ti SA Choice Spine Navigation System SIlverbolt/Mainframe ORIA Claris Connector Claris Lateral Connector, AL06 VEO Lateral Access & Interbody Fusion Sy stem Ascendant Cervical PEEK Spacer Choice Spine Cervical Spacer STEALTH Cervical Spacer STEALTH Cervical Fusion Device Tomcat Cervical Spine System Gilbralt Cannulated Facet Screw Hawkeye Ti Blackhawk Cervical Spacer Gibralt Tiger Shark C ORIA SCS Lateral Intermediate Conn. Raven Lumbar Plate System Typhoon Choice Spine Vertebral Body Replacement (VBR) System Blackhawk Ti Thunderbolt and Lancer Pedicle Screw System ORIA Spinal Clip System (SCS) Spinal Clip System (SCS) SCS SCS CLARIS ORIA CLARIS Harrier Octane Straight ORIA SCS Sacral Connectors ORIA SCS Lengthened Lateral Conn. Types BD & BJ Polyaxial Screws ORIA SCS Polyaxial Screws ORIA SCS Connector Transverse, Large Transverse Connector, Large DTO2 Transverse Connector ORIA Transverse Connector Blackbird HLS (Hinged Laminoplasty System) FALCON Anterior Cervical Plate FALCON ACP Choice Spine ACP System Anterior Cervical Plate (ACP) Gibralt OCP VEO Lateral Access & Interbody Fusion System ORIA System Domino/Tube Connectors Ambassador Harrier-SA Lumbar Interbody System ALTES Thunderbolt & Lancer Pedicle Screws With Hooks Claris Plate System Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusi ORIA CLARIS Claris OmniAxial Connector Claris Connector Harrier-SA ORIA Xena Spinal Clip System Xena Top Loading Polyaxial Screw ORIA Xena Top Clip System Xena Polyaxial Screw Choice Spine Orthopedic Manual Surgical Instrument Various orthopedic screwdrivers ORIA NATURA Spacer NATURA ORIA NATURA NATURA VBR Boomerang Choice Spine STARFIRE Pedicle Screw System STARFIRE Screw STARFIRE Pedicle Screw System Claris Vertebral Screws - V, G, E ORIA SCS Claris Vertebral Screws Proliant LE Pedicle Screw System TigerShark M Interbody System ORIA Spinal Clip System Proliant Typhoon Facet Fixation System Claris System ORIA Claris System SCS 5MM PEDICLE SCREWS Blackbird Spinal System ORIA Cervical Plates Triton SI Fixation System Octane M Various sizes of Taps Choice Spine Lumbar Spacer System; Hornet, Harpoon, Sabre, Shark Silverbolt/Mainframe SCS Claris Extended Omniaxial Conn.

    Establishment Types

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