BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OSSEUS FUSION SYSTEMS LLC

    Reg #: 3010531060 · FEI: 3010531060 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    67
    Establishment Types
    2
    Classifications
    36

    Registration Details

    Registration Name
    OSSEUS FUSION SYSTEMS LLC
    Registration Number
    3010531060
    FEI Number
    3010531060
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1931 Greenville Avenue, Suite 200
    City
    Dallas
    State
    TX
    ZIP
    75206
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222107

    Owner / Operator

    Firm Name
    OSSEUS FUSION SYSTEMS LLC
    Operator Number
    10045353
    Address
    1931 Greenville Avenue, suite 200
    City
    Dallas
    State
    TX
    Postal Code
    75206
    Country
    US

    Products

    Device Name Product Code
    Posterior Cervical Screw System NKG
    Wrench HXC
    Curette HTF
    Rongeur HTX
    Instrument, Bending Or Contouring HXP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Applier, Cerclage HXN
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Guide, Surgical, Instrument FZX
    Tray, Surgical, Instrument FSM
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Orthopedic Stereotaxic Instrument OLO
    Orthopedic Manual Surgical Instrument LXH
    Thoracolumbosacral Pedicle Screw System NKB
    Sacroiliac Joint Fixation OUR
    Instrument, Compression HWN
    Retractor GAD
    Probe HXB
    Tap, Bone HWX
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Reamer HTO
    Tamp HXG
    Crimper, Pin HXQ
    Rasp HTR
    Pliers, Surgical HTC
    Screwdriver HXX
    Awl HWJ
    Bit, Drill HTW
    Forceps, Wire Holding HYA
    Mallet HXL
    Caliper KTZ
    Bender HXW

    Proprietary Names

    Black Diamond POCT Quick Connect Ratchet Handle RATCHET HANDLE, PREF ACP Rod Persuader PLATE BENDER, PREF ACP White Pearl ACP Cervical Plate Gemini-C interbody WIRE INTRODUCER, PREF ACP LLIF Inserter Aries Lumbar Interbody K-wire DRILL GUIDE, PREF ACP Instrument tray PISCES-SA ALIF Interbody Black Diamond Stereotaxic Instruments Rod Pusher FIXATION PIN, PREF ACP Rod Rocker FIXATION PIN INSERTER, PREF ACP FIXATION SCREW, PREF ACP LOCKING DRIVER, PREF ACP Rod Passer Driver GUIDE WIRE, PREF ACP Rod Holder Gemini-C Inserter Gemini-C Trial Black Diamond PSS 13X50MM IMPLANT 3.2MM STEINMANN PIN, SHARP 13MM WASHER 13X60MM IMPLANT 13X45MM IMPLANT 11X60MM IMPLANT 11MM WASHER 11X55MM IMPLANT 13X35MM IMPLANT 11X50MM IMPLANT 11X40MM IMPLANT 11X35MM IMPLANT Blue Topaz CompreSIve Sacroiliac Screw System 3.2MM STEINMANN PIN, ROUND 13X40MM IMPLANT 11MM DRILL, CANNULATED 11X45MM IMPLANT 13X55MM IMPLANT Compressor Distractor Bone Probe Bone Tap TAP, PREF ACP Gemini-C tamp LLIF STRAIGHT TAMP, ARIES-L Screw Tab Breaker Pedicle Bone Deburrer Gemini-C Rasp LATERAL RASP, ARIES L Rod Passer Screw Driver SCREW INSERTER, PREF ACP awl AWL, PREF ACP DRILL, PREF ACP Rod Forceps MALLET NEURO CALIPERS, PREF ACP Blue Topaz Sacroiliac Screw System Rod Bender

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device