BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Engineered Medical Systems, LLC

    Reg #: 3009973336 · FEI: 3009973336 · Expires 2026
    View on FDA
    Products
    97
    Proprietary Names
    80
    Establishment Types
    1
    Classifications
    97

    Registration Details

    Registration Name
    Engineered Medical Systems, LLC
    Registration Number
    3009973336
    FEI Number
    3009973336
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3325 Appling Rd
    City
    Bartlett
    State
    TN
    ZIP
    38133
    Country
    US

    Owner / Operator

    Firm Name
    Engineered Medical Systems, LLC
    Operator Number
    10042524
    Address
    3325 Appling Road
    City
    Bartlett
    State
    TN
    Postal Code
    38133
    Country
    US
    Correspondent
    Dwayne Wisham

    Products

    Device Name Product Code
    Clamp HXD
    Bone Fixation Cerclage, Sublaminar OWI
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthopedic Stereotaxic Instrument OLO
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Reamer HTO
    Prosthesis, Intervertebral Disc MJO
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN
    Plate, Fixation, Bone HRS
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Gauge, Depth HTJ
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Tamp HXG
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Stimulator, Nerve ETN
    Chisel, Surgical, Manual FZO
    Bender HXW
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Awl HWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Rod, Fixation, Intramedullary And Accessories HSB
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Chisel (Osteotome) KDG
    Posterior Cervical Screw System NKG
    Probe HXB
    Neurological Stereotaxic Instrument HAW
    Stimulator, Electrical, Evoked Response GWF
    Electromyograph, Diagnostic IKN
    Camera, Focal Spot, Radiographic IXH
    Template HWT
    Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer KRQ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Tap, Bone HWX
    Orthosis, Spinal Pedicle Fixation MNI
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Spinal Vertebral Body Replacement Device MQP
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Orthopedic Manual Surgical Instrument LXH
    Bone Wedge PLF
    Impactor HWA
    Osteotome, Manual GFI
    Handle, Scalpel GDZ
    Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices QLR
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Sacroiliac Joint Fixation OUR
    Guide, Surgical, Instrument FZX
    Pin, Fixation, Smooth HTY
    Device, Fixation, Proximal Femoral, Implant JDO
    Mallet HXL
    Screwdriver HXX
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Computer, Blood-Pressure DSK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Monitor, Breathing Frequency BZQ
    Monitor, Apnea, Facility Use FLS
    Oximeter DQA
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Continuous Measurement Thermometer FLL
    Monitor, St Segment With Alarm MLD
    Bit, Drill HTW
    Tape, Measuring, Rulers And Calipers FTY
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Cerclage, Fixation JDQ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Rasp HTR
    Instrument, Manual, Surgical, General Use MDM
    Retractor GAD
    Accessories, Arthroscopic NBH
    Light, Surgical, Carrier FSZ
    Light, Surgical, Fiberoptic FST
    Caliper KTZ
    Elevator, Surgical, General & Plastic Surgery GEG
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Maxwell Spot, Ac-Powered HIX
    Vertebral Body Tethering System QHP

    Proprietary Names

    Custom Onlay Patellar Tensioner REAMER Small Oblique Inserter GAUGE, DEPTH CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS Journey STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES BRYAN CERVICAL DISC BENDER REDAPT MODULAR PROXIMALLY FLUTED HIP STEM TL Tubing Set (STERILE) PL Tubing Set (STERILE) PROBE Adapter Cap TEMPLATE FOR CLINICAL USE TOTAL KNEE SYSTEM INSTRUMENTATION TAP, BONE CD HORIZON SPINAL SYSTEM VERTE-STACK SPINAL SYSTEM Sequential Reducer X-Core Mini INTREPID SPINAL SYSTEM Inserter PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM HANDLE, SCALPEL Orthosis, spondylolisthesis spinal fixation Appliance, Fixation, Spinal Interl Orthosis, spinal pedicle fixation, for degenerative disc disease Orthosis, Spinal Pedicle Fixation Appliance, Fixation, Spinal Intervertebral Body IPC POWEREASE SYSTEM Adjustment Driver inserter Drive Shaft 8mm TL Trial TL Insertion Handle 10mm PL Trial 10mm TL Trial 6mm TL Trial Instrument Tray Lid Graft Insertion Cannula Insertion Handle Rotator Knob TL Insertion Handle Inner Shaft Graft Insertion Pusher PL Insertion Handle Insertion Handle End Cap TL Instrument Set (Long Trial Handles) Slap Hammer 8mm PL Trial 6mm PL Trial Instrument Tray Base Prep Block PL Insertion Handle Inner Shaft Instrument Tray Insert PL Instrument Set (Long Trial Handles) GUIDE, SURGICAL, INSTRUMENT Peri-Loc MALLET Syringe Body Syringe Plunger TL Tubing Set (Sterile) Syringe Body Green O-Ring PL Tubing Set (Sterile) Syringe Plunger Red O-Ring PERIMETER INTERBODY FUSION DEVICE Femoral Head/Neck Impactor Disposable Instrument Freehand Inserter Sleeve Tape SMF Stem Osteotomy Guide PYRAMID ANTERIOR PLATE FIXATION SYSTEM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE RETRACTOR TL Instrument Set (Short Trial Handles) PL Instrument Set (Short Trial Handles) PEEK PREVAIL CERVICAL INTERBODY DEVICE Orthosis, Spondylolisthesis Spinal Fixation Perimeter Spinal System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)