BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K2M, INC.

    Reg #: 3004774118 · FEI: 3008599177 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    164
    Establishment Types
    5
    Classifications
    46

    Registration Details

    Registration Name
    K2M, INC.
    Registration Number
    3004774118
    FEI Number
    3008599177
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    600 Hope Pkwy SE
    City
    Leesburg
    State
    VA
    ZIP
    20175
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080611

    Owner / Operator

    Firm Name
    VB Spine, LLC
    Operator Number
    10093189
    Address
    505 Park Avenue, 14th Floor
    City
    New York
    State
    NY
    Postal Code
    10022
    Country
    US
    Correspondent
    Christopher Tortora

    Products

    Device Name Product Code
    Rongeur HTX
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Awl HWJ
    Cerclage, Fixation JDQ
    Bit, Drill HTW
    Caliper KTZ
    Gauge, Depth HTJ
    Spinal Vertebral Body Replacement Device MQP
    Thoracolumbosacral Pedicle Screw System NKB
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Orthopedic Stereotaxic Instrument OLO
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Posterior Cervical Screw System NKG
    Probe HXB
    Passer, Wire, Orthopedic HXI
    Instrument, Compression HWN
    Extractor HWB
    Bone Fixation Cerclage, Sublaminar OWI
    Instrument, Biopsy KNW
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Intervertebral Disc MJO
    Impactor HWA
    Knife, Orthopedic HTS
    Bender HXW
    Wrench HXC
    Spinal Fixation System PWG
    Brace, Drill HXY
    Tray, Surgical, Instrument FSM
    Template HWT
    Tap, Bone HWX
    Tamp HXG
    Filler, Bone Void, Calcium Compound MQV
    Cutter, Wire HXZ
    Fork HXE
    Screwdriver HXX
    Growing Rod System PGM

    Proprietary Names

    RONGEUR General Instruments MESA SPINAL SYSTEM Mojave Range, Ari Pyrenees AWL NILE CoCr Wire MANUAL DRILL BIT DRILL BIT Caliper Depth Gauge Capri CASPIAN SPINAL SYSTEM Range (Mesa, Denali) Everest Vulcan Spinal System Ozark ALEUTIAN IBF SYSTEM Range, Denali, Mesa Chesapeake Cervical Cayman Caspian OCT/Mesa mini/Denali mini PALO ALTO Corpectomy Cage System PYRENEES SPINAL SYSTEM Pyrenees, Blue Ridge XIA 3 Yukon OCT Spinal System Napa Access System PROBE WIRE (ALL) COMPRESSOR COMPACTOR/COMPRESSION Q Interbody Instruments Extractor Cascadia Nile Aleutian Fenestrated Tap System Cascadia Interbody System ORTHOPEDIC MANUAL UniVise Orthopaedic Manual Instrumentation Terra Nova, Ravine, Serengeti, VCR, Cricket Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest Screw Insertion Sleeve NAPA Access System Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini Drill Bit Rhine SAHARA Stabilization System Caspian Spinal System RANGE SPINAL SYSTEM, SMALL STATURE Yukon K2M Navigation Instruments Range Spinal System; with pediatric indications Impactor, Orthopedic Manual Surgical Instrument ALEUTIAN SPACER SYSTEM MESA DENALI DEFORMITY SYSTEM KNIFE ALEUTIAN AN SPACER SYSTEM RANGE SPINAL SYSTEM Everest, Range, Mesa, Denali Everest Spinal System Everest Aleutian IBF System Aero™-LL Lumbar Cage System Tritanium® PL Cage Aero™-AL Lumbar Cage System Monterey™ AL Interbody System Mojave Expandable Interbody System AVS® Anchor-L Spacer Ascential IBD PEEKc Spacer AVS® UniLIF PEEK Spacer Tritanium® X PL Expandable Posterior Lumbar Cage Aero®-C Cervical Cage System AVS® TL PEEK Spacer Stryker Spine VLIFT™ Vertebral Body Replacement System AVS® PL PEEK Spacer Tritanium® TL Curved Posterior Lumbar Cage Capri Corpectomy Cage System VLIFT®-s Vertebral Body Replacement System AVS® Aria PEEK Spacer Chesapeake Stabilization System AVS® Anchor-C Cervical Cage System Tritanium® X TL Expandable Curved Posterior Lumbar Cage Tritanium® C Anterior Cervical Cage AVS® Navigator PEEK Spacer AVS® AL PEEK Spacer AVS® AS PEEK Spacer Santorini Corpectomy Cage System Sahara Stabilization System Caspian OCT Spinal System Navigated Spine Instruments PYRENEES CERVICAL PLATE SYSTEM SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System Caspian Sahara Bender Caspian, Mesa mini, Denali mini Brainlab RANGE SPINAL SYSTEM (MESA AND DENALI) K2M Patient Specific Rods Chesapeake Spinal System EVEREST SPINAL SYSTEM Range Spinal System NATURAL BRIDGE Chesapeake ALEUTIAN CAYMAN SPINAL SYSTEM Rigid Rail DRILL GUIDE Range, Small Stature, Mesa Range Mesa Denali EVEREST Spinal System CAPRI Corpectomy Cage System ALEUTIAN SYSTEM YUKON OCT Spinal System Trays OZARK Cervical Plate System Trays DENALI Spinal System Trays Navigated Spine Instruments Trays CASPIAN Spinal System Trays MESA Spinal System Trays CAYMAN Plate System Trays PYRENEES Cervical Plate System Trays ALEUTIAN Interbody Systems Trays SAHARA Stabilization System Trays RAVINE Access System Trays EVEREST Spinal System Trays CHESAPEAKE Stabilization System Trays CAPRI Corpectomy Cage System Trays CANYON Retractor Systems Trays K2M Mesa Modular Hooks XIA Rod Template Vikos Allograft System Xia Blocker Inserter K2M General Instruments Aleutian Spacer System Chesapeake Lumbar Range/Mesa.Denali Spinal System Caspian OCT, Mesa Mini, Denali Mini DENALI CAYMAN BUTTRESS TAP CAYMAN Range/Mesa/Denali TAMP YUKON OCT Spinal System Nile Alternative Fixation Q Pedicle Instruments Range, Mesa, Denali, Natural Bridge Venado Cascadia, Cayman United Santorini RANGE COCR ROD WIRE CUTTER ADJUSTMENT FORK Range (Mesa, Denali) CASPIAN MESA SPINAL SYSTEM (KEYSTONE RAIL RODS) Screwdriver K2M Growing Spine System Range/Mesa/Denali Spinal System CAYMAN LP Plate System

    Establishment Types

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