BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alphatec Spine, Inc.

    Reg #: 3019878714 · FEI: 3019878714 · Expires 2026
    View on FDA
    Products
    74
    Proprietary Names
    169
    Establishment Types
    4
    Classifications
    74

    Registration Details

    Registration Name
    Alphatec Spine, Inc.
    Registration Number
    3019878714
    FEI Number
    3019878714
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4101 Willow Lake Blvd.
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143149

    Owner / Operator

    Firm Name
    ALPHATEC HOLDINGS, INC.
    Operator Number
    9072657
    Address
    1950 Camino Vida Roble
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Brian - Beireis

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Mallet HXL
    System, Image Processing, Radiological LLZ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Appliance, Fixation, Spinal Interlaminal KWP
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Bone Fixation Cerclage, Sublaminar OWI
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Elevator HTE
    Knife, Orthopedic HTS
    Bit, Drill HTW
    Curette HTF
    Guide, Surgical, Instrument FZX
    Needle, Aspiration And Injection, Disposable GAA
    Dissector, Surgical, General & Plastic Surgery GDI
    Tap, Bone HWX
    System, Facet Screw Spinal Device MRW
    Trephine HWK
    Starter, Bone Screw HWD
    Screwdriver HXX
    Orthopedic Stereotaxic Instrument OLO
    Forceps HTD
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Posterior Cervical Screw System NKG
    Neurosurgical Nerve Locator PDQ
    Stimulator, Nerve ETN
    Bender HXW
    Bone Cement, Posterior Screw Augmentation PML
    Chisel, Surgical, Manual FZO
    Broach HTQ
    Reamer HTO
    Osteotome, Manual GFI
    Support, Patient Position CCX
    Spinal Vertebral Body Replacement Device MQP
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Retractor, Fiberoptic FDG
    Rasp HTR
    Awl HWJ
    Catheter And Tip, Suction JOL
    Electrode, Cutaneous GXY
    Electrode, Needle GXZ
    Electromyograph, Diagnostic IKN
    Stimulator, Electrical, Evoked Response GWF
    Light, Surgical, Accessories FTA
    Rongeur HTX
    Probe HXB
    Instrument, Cutting, Orthopedic HTZ
    Impactor HWA
    Wrench HXC
    Caliper KTZ
    Sacroiliac Joint Fixation OUR
    Retractor GAD
    Instrument, Compression HWN
    Instrument, Bending Or Contouring HXP
    Table, Operating-Room, Pneumatic FWW
    Table, Operating-Room, Ac-Powered FQO
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Tray, Surgical, Instrument FSM
    Gauge, Depth HTJ
    Tamp HXG
    Handle, Scalpel GDZ
    Cable, Electrode IKD
    Forceps, Wire Holding HYA
    Template HWT
    Driver, Prosthesis HWR

    Proprietary Names

    Orthopedic Manual Surgical Instrument Arsenal Spinal Fixation System Arsenal CBx Mallet VEA Sterilization Container used with Remi Robotic Navigation System IdentiTi NanoTec Interbody System IdentiTi Cervical Standalone Interbody System Transcend NanoTec Interbody System IdentiTi NanoTec ALIF Standalone Interbody System IdentiTi ALIF Standalone Interbody System IdentiTi Porous Ti Interbody System IdentiTi NanoTec Cervical Standalone Interbody System Transcend PEEK Interbody System Zodiac Lumbar Spinal Fixation System Alphatec Spine Posterior Cervico-Thoracic Spinal Fixation System Avalon Occipital Plate Solanas Posterior Cervico-Thoracic Spinal Fixation System Invictus Calibrate NanoTec PSX Interbody System Calibrate PSX Interbody System Solanas ATEC Porous Ti (PTi) Thoracolumbar Spacer System Batalion Lumbar Spinal Spacer Solanas® Posterior Stabilization System IdentiTi Cervical Porous Ti Interbody System Transcend Cervical PEEK Interbody System IdentiTi NanoTec Cervical Interbody System Transcend NanoTec Cervical Interbody System IdentiTi NanoTec Cervical Standalone Interbody Sytem IdentiTi Leucadia Cross Connectors ALLEZ SPINE Cross Connectors Battalion Lumbar Spacer System Battalion Universal Spacer System Cobb Elevator PSX Calibrate PSX Insignia Anterior Cervical Plate System Orthopedic Knife Drill Bit Curette Kodiak Spinal Fixation System Invictus Spinal Fixation System Guide, Surgical, Instrument Targeting Needle Disposable Aspiration and Injection Needle Surgical Dissector, General & Plastic Surgery Bone Tap Illico FS Facet Fixation System Transcend™ NanoTec™ SPS Interbody System IdentiTi™ SPS Interbody System Transcend™ SPS Interbody System Segmental Plating System (SPS) IdentiTi™ NanoTec™ SPS Interbody System ZODIAC Spinal Fixation System Trestle Luxe® II Anterior Cervical Plating System Trestle Luxe® Anterior Cervical Plating System Calibrate NanoTec CCX Interbody System Calibrate CCX Interbody System Bridgepoint Spinous Process Fixation System Trephine STARTER, BONE SCREW Screwdriver Calibrate LTX Interbody System Calibrate NanoTec LTX Interbody System IdentiTi II Cervical Interbody System Phygen Leucadia Leucadia Pedicle Screw System IdentiTi II and Transcend ALIF Standalone Interbody Systems ATEC Lateral Navigation Instruments Invictus Robotic Navigation Instruments Forceps Power Adaptor Avalon Occipital Fixation System Solanas Posterior OCT Fixation System AlphaInformatix SafeOp EPAD2 Proximity Anterior Cervical Plate System Bender Invictus Bone Cement, Invictus Spinal Fixation System Zodiac Spinal Fixation System Illico MIS Posterior Spinal Fixation System Pegasus Inserter Invictus Small Stature Spinal Fixation System Surgical Chisel, Manual Broach Aspida Anterior Lumbar Plating System Invictus OsseoScrew System Reamer Osteotome Remi Robotic Navigation System Illico MIS Posterior Fixation System LIF Instruments IdentiTi and Transcend Interbody Systems Novel Interbody Spinal System (ACC/LCC) IntraOp Alignment System Illumination System RASP Awl Illico MIS IdentiTi II Interbody System AMP II SafeOp 3 System Illico AMP-LTX System Core ROC Arsenal Spinal Fixation System, Degenerative LIF Anti-Migration Plate (AMP) Transcend Interbody System Rongeur Probe Novel Cervical Interbody Spinal Spacer System Novel CIS/XS Interbody Spinal Spacer System(s) Novel Spinal Spacer System Cutting Instrument, Orthopedic Impactor Novel Interbody Spinal Spacer System (LCC/SD/XS) Valence Robotic Navigation System ATEC Posterior Navigated Disc Prep Instruments Wrench OsseoScrew System Caliper Retractor Arsenal Cannulated Arsenal Spinal Fixation System, Cannulated Compressor/Distractor Compressor Bending Instrument ATEC A.R.M. Solus Anterior Lumbar Interbody Fusion (ALIF) System Solus Anterior Lumbar Interbody Fusion Ascend VBR System Novel ALS Interbody Spinal Spacer System Trestle Avalon Sigma Kodiak AMP Alphagraft Bridgepoint Osseoscrew Novel Battalion Aspida Xenon Zodiac Arsenal Alphatec Navigation Instruments Illico MIS® Arsenal® Arsenal System, Deformity Gauge Depth Gauge AlphaInfomatix EPAD 2 Insignia Tamp Scalpel Handle SafeOp 3: Neural Informatix System Battalion Lumbar Spinal Spacer System FORCEPS, WIRE HOLDING Template DRIVER, PROSTHESIS IdentiTi ALIF Oblique Interbody System IdentiTi ALIF Narrow Interbody System

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility