BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XENIX MEDICAL

    Reg #: 3012429289 · FEI: 3012429289 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    142
    Establishment Types
    3
    Classifications
    19

    Registration Details

    Registration Name
    XENIX MEDICAL
    Registration Number
    3012429289
    FEI Number
    3012429289
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    149 W Michigan St
    City
    Orlando
    State
    FL
    ZIP
    32806
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231829

    Owner / Operator

    Firm Name
    Xenix Medical
    Operator Number
    10051846
    Address
    149 W Michigan St.
    City
    Orlando
    State
    FL
    Postal Code
    32806
    Country
    US
    Correspondent
    Ryan Phillips

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR
    Orthopedic Stereotaxic Instrument OLO
    Screw, Fixation, Bone HWC
    Screwdriver HXX
    Accessories, Fixation, Spinal Intervertebral Body LYQ
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Reamer HTO
    Tray, Surgical, Instrument FSM
    Tray, Surgical LRP
    Orthopedic Manual Surgical Instrument LXH
    Template HWT
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Tap, Bone HWX
    Probe HXB
    Instrument, Compression HWN
    Wrench HXC
    Bender HXW

    Proprietary Names

    Xenix Medical Sacroiliac Fixation System RIVA Posterior Fixation System Screw Adjuster RIVA Posterior Fixation System Shank Head Adjuster - Grey RIVA Posterior Fixation System Head Turner - T-Handle RIVA Posterior Fixation System Set Screw Inserter - Long RIVA Posterior Fixation System Head Turner - Axial RIVA Posterior Fixation System Head Remover RIVA Posterior Fixation System Set Screw Inserter RIVA Posterior Fixation System Set Screw Inserter - Short RIVA Posterior Fixation System Shank Head Adjuster - Green RIVA Posterior Fixation System BONE SCREW INSERTER RIVA Posterior Fixation System Set Screw Inserter, Double Sided RIVA Posterior Fixation System Rod Inserter RIVA Posterior Fixation System Head Inserter TiWave TiWave-C neoWave C Ti3D RIVA Posterior Fixation System Bone Reamer TiWave-L neoWave LS RIVA Posterior Fixation System Reduction Head Caddy Base RIVA Posterior Fixation System Standard Head Caddy Lid RIVA Posterior Fixation System 5.5 Cross Connector Caddy Lid RIVA Posterior Fixation System 4.5/8.5 Screw Caddy Base RIVA Posterior Fixation System 6.5 Screw Caddy Lid RIVA Posterior Fixation System Reduction Head Caddy Lid RIVA Posterior Fixation System Lordotic Rod Caddy Base RIVA Posterior Fixation System Specialty Head and Connector Caddy Base RIVA Posterior Fixation System 5.5 Cross Connector Caddy Base RIVA Posterior Fixation System 5.5 Screw Caddy Lid RIVA Posterior Fixation System 7.5 Screw Caddy Lid RIVA Posterior Fixation System Set Screw Caddy Base RIVA Posterior Fixation System 4.5/8.5 Screw Caddy Lid RIVA Posterior Fixation System Lordotic Rod Caddy Lid RIVA Posterior Fixation System 6.5 Screw Caddy Base RIVA Posterior Fixation System 5.5 Screw Caddy Base RIVA Posterior Fixation System 7.5 Screw Caddy Base RIVA Posterior Fixation System Standard Head Caddy Base RIVA Posterior Fixation System Set Screw Caddy Lid RIVA Posterior Fixation System Specialty Head and Connector Caddy Lid RIVA Posterior Fixation System Implant Set Top Level RIVA Posterior Fixation System Pedicle Screw Instrument Set 2 Top Level RIVA Posterior Fixation System Pedicle Screw Instrument Set 1 Bottom Level RIVA Posterior Fixation System Implant Set Bottom Level RIVA Posterior Fixation System Pedicle Screw Instrument Set 2 Lid RIVA Posterior Fixation System Pedicle Screw Instrument Set 1 Top Level RIVA Posterior Fixation System Pedicle Screw Instrument Set 1 Lid RIVA Posterior Fixation System Implant Tray Lid RIVA Posterior Fixation System Pedicle Screw Instrument Set 1 Base RIVA Posterior Fixation System Implant Tray Base RIVA Posterior Fixation System Pedicle Screw Instrument Set 2 Base RIVA Posterior Fixation System Pedicle Screw Instrument Set 2 Middle Level Xenix Medical RIVA Posterior Fixation System Rod Gripper RIVA Posterior Fixation System Distractor RIVA Posterior Fixation System Counter Torque - Long RIVA Posterior Fixation System Rod Rocker RIVA Posterior Fixation System Final Tightener - Short RIVA Posterior Fixation System Extended Tab Breaker, Tube RIVA Posterior Fixation System Counter Torque - Short RIVA Posterior Fixation System Axial Rod Reducer RIVA Posterior Fixation System Axial Reducer Driver RIVA Posterior Fixation System Axial Reducer Counter Torque RIVA Posterior Fixation System Final Tightener - Long RIVA Posterior Fixation System Screwdriver, Closed Head RIVA Posterior Fixation System Screwdriver, Standard RIVA Posterior Fixation System FINAL TIGHTENER, CROSSBAR RIVA Posterior Fixation System Screwdriver, Adjustable RIVA Posterior Fixation System Counter Torque RIVA Posterior Fixation System Final Tightener RIVA Posterior Fixation System Screwdriver, Reduction RIVA Posterior Fixation System COUNTER TORQUE, CROSSBAR RIVA Posterior Fixation System Extended Tab Remover, Plier RIVA Posterior Fixation System Rod Template, 200mm RIVA Posterior Fixation System Screw Measurement and Holder RIVA Posterior Fixation System Rod Template, 450mm RIVA Posterior Fixation System RIVA Posterior Fixation System Navigation Instruments LUX Expandable Lumbar Interbody System Ti3D Cervical NANOACTIV RIVA Posterior Fixation System Cannulated Iliac Tap, 6.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 10.5mm RIVA Posterior Fixation System Pedicle Tap, 7.5mm RIVA Posterior Fixation System Pedicle Tap, 9.5mm RIVA Posterior Fixation System Iliac Tap, 11.5mm RIVA Posterior Fixation System Pedicle Tap, 5.5mm RIVA Posterior Fixation System Iliac Tap, 7.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 5.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 5.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 12.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 8.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 7.5mm RIVA Posterior Fixation System Iliac Tap, 12.5mm RIVA Posterior Fixation System Pedicle Tap, 3.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 4.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 11.5mm RIVA Posterior Fixation System Iliac Tap, 8.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 8.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 9.5mm RIVA Posterior Fixation System Iliac Tap, 9.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 12.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 8.5mm RIVA Posterior Fixation System Pedicle Tap, 10.5mm RIVA Posterior Fixation System Pedicle Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 7.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 8.5mm RIVA Posterior Fixation System Pedicle Tap, 8.5mm RIVA Posterior Fixation System Pedicle Tap, 4.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 9.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 10.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 10.5mm RIVA Posterior Fixation System Pedicle Tap, 11.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 4.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 10.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 3.5mm RIVA Posterior Fixation System Pedicle Tap, 12.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 11.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 12.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 7.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 11.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 7.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 9.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 12.5mm RIVA Posterior Fixation System Iliac Tap, 10.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 11.5mm RIVA Posterior Fixation System Iliac Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 9.5mm RIVA Posterior Fixation System French Rod Bender RIVA Posterior Fixation System Compressor NeoFuse LUX Expandable Interbody System Wrench RIVA Posterior Fixation System CORONAL BENDER FULCRUM RIVA Posterior Fixation System 5.5 CORONAL BENDER - R RIVA Posterior Fixation System 6 CORONAL BENDER - L RIVA Posterior Fixation System 5.5 CORONAL BENDER - L RIVA Posterior Fixation System 6 CORONAL BENDER - R SOLACE Sacroiliac Fixation System

    Establishment Types

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