BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CAMBER SPINE TECHNOLOGIES

    Reg #: 3010197239 · FEI: 3010197239 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    57
    Establishment Types
    5
    Classifications
    34

    Registration Details

    Registration Name
    CAMBER SPINE TECHNOLOGIES
    Registration Number
    3010197239
    FEI Number
    3010197239
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    501 Allendale Rd
    City
    King of Prussia
    State
    PA
    ZIP
    19406
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180724

    Owner / Operator

    Firm Name
    Camber Spine/Medical Technologies
    Operator Number
    10043961
    Address
    501 Allendale Rd.
    City
    King of Prussia
    State
    PA
    Postal Code
    19406
    Country
    US

    Products

    Device Name Product Code
    Rasp HTR
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Tap, Bone HWX
    Awl HWJ
    Probe HXB
    Rongeur HTX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Needle, Aspiration And Injection, Reusable GDM
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Hammer, Surgical FZY
    Syringe, Piston FMF
    Caliper KTZ
    Orthopedic Stereotaxic Instrument OLO
    Camera, Surgical And Accessories KQM
    Filler, Bone Void, Calcium Compound MQV
    Retractor GAD
    System, X-Ray, Film Marking, Radiographic JAC
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Tray, Surgical, Instrument FSM
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Chisel, Surgical, Manual FZO
    Mallet HXL
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Orthopedic Manual Surgical Instrument LXH
    Bit, Drill HTW
    Curette HTF
    Guide, Surgical, Instrument FZX
    Tamp HXG
    Gauge, Depth HTJ
    Screwdriver HXX

    Proprietary Names

    Rasp SPIRA®-L Open Matrix LLIF Bone Tap Awl SPIRA™ Open Matrix ALIF Pinnacle Lateral Implants Probe Rongeur ALTIVO Anterior Cervical Fixation System Aspiration needle SPIRA-O Open Matrix OLIF Surgical Hammer INFILL Graft Delivery System Diagon Oblique Cage Caliper Camber Spine Navigation System OLIF Retractor Light Source Scylla OLIF Retractor Articulating Inserter Handle, Lateral OLIF Retractor Articulating Inserter Handle OLIF Retractor Articulating Handle Hex Shaft OLIF Retractor Articulating Inserter Slap Hammer Cap OLIF Disc Marking Tool Spira-TA Enza-A Titanium ALIF OLIF Disc Prep Tray #1 OLIF Retractor, Blade Tray #3 PSG 5.5mm Cannulated Pedicle Screw System Ti-Diagon Oblique TLIF Chisel Mallet SPIRA-C Open Matrix Cervical Interbody Spira-P Posterior Lumbar Spacer Spira-T Inserter Spira-T Posterior Lumbar Spacer Spira-P Inserter Verta Corpectomy Cage Orthros MIS Coveris Cage Alcantara Thoracolumbar Plate System Spira Anterior Lumbar Spacers SPIRA-V Open Matrix Corpectomy Cage Spira-C MANUS Carpal Ligament Knife Bone Buddies Bone Harvester Drill Bit TLS 5 Interbody Cage Coveris Cervical Cage Curette Orthros Posterior Stabilization System Drill Guide Tamp BIA-GEN Depth Gauge Screwdriver Enza Zero-Profile Anterior Interbody Fusion Enza-O

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only