BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xtant Medical Holdings, Inc.

    Reg #: 3005031160 · FEI: 3005031160 · Expires 2026
    View on FDA
    Products
    56
    Proprietary Names
    115
    Establishment Types
    4
    Classifications
    56

    Registration Details

    Registration Name
    Xtant Medical Holdings, Inc.
    Registration Number
    3005031160
    FEI Number
    3005031160
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    664 Cruiser Lane
    City
    Belgrade
    State
    MT
    ZIP
    59714
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133455

    Owner / Operator

    Firm Name
    Xtant Medical Holdings, Inc.
    Operator Number
    10028385
    Address
    664 Cruiser Lane
    City
    Belgrade
    State
    MT
    Postal Code
    59714
    Country
    US
    Correspondent
    Rebecca Lennemann

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Filler, Bone Void, Calcium Compound MQV
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    System, Facet Screw Spinal Device MRW
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Clamp HXD
    Tamp HXG
    Awl HWJ
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Rasp HTR
    Tap, Bone HWX
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Wrench HXC
    Pliers, Surgical HTC
    Brace, Drill HXY
    Sacroiliac Joint Fixation OUR
    Guide, Surgical, Instrument FZX
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Bit, Drill HTW
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Posterior Cervical Screw System NKG
    Guide, Needle, Surgical GDF
    Forceps HTD
    Elevator HTE
    Template HWT
    Rongeur HTX
    Tray, Surgical LRP
    Instrument, Bending Or Contouring HXP
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Handle, Scalpel GDZ
    Spinous Process Plate PEK
    Extractor HWB
    Driver, Surgical, Pin GFC
    Osteotome, Manual GFI
    Screwdriver HXX
    Instrument, Compression HWN
    Dissector, Surgical, General & Plastic Surgery GDI
    Curette HTF
    Mallet HXL
    Broach HTQ
    Instrument, Cutting, Orthopedic HTZ
    Gauge, Depth HTJ
    Impactor HWA
    Bender HXW
    Device, Percutaneous, Biopsy MJG
    Probe HXB
    Orthopedic Manual Surgical Instrument LXH
    Knife, Surgical EMF
    Retractor GAD
    Caliper KTZ
    Fork HXE

    Proprietary Names

    Cross-Fuse II PEEK IBF System nanOss 3D Plus Advanced Bone Graft Substitute nanOss 3D Advanced Bone Graft Substitute CervAlign Lat-Fuse Lateral Plate System Zyfix Spinal Facet Screw System OsteoSelect Clamp Tamp Cequence Anterior Cervical Plate System PAC Anterior Cervical Plate Awl Streamline MIS Spinal Fixation System Calix PC Spinal Implant System Xpress Pedicle Screw System Fortex Pedicle Screw System Streamline TL Spinal Fixation System Rasp Bone Tap Irix-C Cervical Integrated Fusion System Wrench Handle Pliers Drill Brace Silex Sacroiliac Joint Fusion System Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology Spider Cervical Plating System MaxFuse PEEK VBR Calix Lumbar Spinal Implant System Cortera Spinal Fixation System Streamline OCT Occipito-Cervico-Thoracic System Tissue Shield Instrument Guide Xspan Laminoplasty Fixation System Fixcet Spinal Facet Screw System Cervalign Anterior Cervical Plate System nanOss Loaded Advanced Bone Graft Substitute nanOss Advanced Bone Graft Substitute Influx ProSpace BEAST Reficio VIA CuriGraft Hero GTR Axle Interspinous Fusion System Drill Bit Irix-A Lumbar Integrated Fusion System Streamline OCT Guide Needle Needle Guide Pin Cortera Quantum Spinal Fixation System Calix-C Cervical Interbody Spacer Aspect Anterior Cervical Plate System SlimFuse Anterior Cervical Plate System Contact ALP Axle PEEK Interspinous Fusion System Calix Spinal Implant System TiPlus Forceps Elevator Trial Sizer Template Rongeur Surgical Tray Wire cutter Rod cutter Adaptor, 1/4" Square/Jacobs Chuck Scalpel Handle Axle-X Interspinous Fusion System Unison-C Anterior Cervical Fixation System BiomaX Aranax Anterior Cervical Plating System Extractor Distractor Pin Driver Osteotome Screwdriver Compressor Dissector Curette Contact IBF System Fortilink®-TS IBF System Fortilink®-C IBF System Fortilink® IBF System with TETRAfuse®3D Technology Fortilink®-L I BF System Mallet OsteoPore Plus OsteoSelect, OsteoSelect Plus Influx Plus MAXX Fuse Broach Cutting Instrument Depth Gauge Impactor Inserter Streamline OCT-Occipito-Cervico-Thoracic System Bender InTice-C Porous Ti Cervical Interbody System C-Plus Fortilink™-C with TETRAfuse™ 3D Technology Biopsy Needle Probe X-spine Pedicle Screw System Orthopedic Manual Surgical Instrument T-Plus Knife IRIX-A Lumbar Integrated Fusion System Retractor Caliper Fork

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility