BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QUALITY TECH SERVICES, LLC

    Reg #: 3003477135 · FEI: 3003477135 · Expires 2026
    View on FDA
    Products
    149
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    149

    Registration Details

    Registration Name
    QUALITY TECH SERVICES, LLC
    Registration Number
    3003477135
    FEI Number
    3003477135
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10525 Hampshire Ave. S.
    City
    Bloomington
    State
    MN
    ZIP
    55438
    Country
    US

    Owner / Operator

    Firm Name
    QUALITY TECH SERVICES, LLC
    Operator Number
    9047880
    Address
    10525 Hampshire Ave. S., --
    City
    Bloomington
    State
    MN
    Postal Code
    55438
    Country
    US

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Orthopedic Tray OJH
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Spinal Vertebral Body Replacement Device MQP
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Prosthesis, Toe, Constrained, Polymer KWH
    Stimulator, Nerve ETN
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    System, X-Ray, Tomography, Computed JAK
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Passer, Wire, Orthopedic HXI
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Fastener, Plate, Cranioplasty HBW
    Cover, Burr Hole GXR
    Plate, Cranioplasty, Preformed, Alterable GWO
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Probe, Test, Heart-Valve LXN
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained LZJ
    High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis OMX
    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis NEG
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Accessories, Implant, Dental, Endosseous NDP
    Accelerator, Linear, Medical IYE
    Prosthesis, Wrist, Carpal Trapezium KYI
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Neurological Stereotaxic Instrument HAW
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Gauge, Depth HTJ
    Bit, Surgical GFG
    Screwdriver HXX
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Transducer, Miniature Pressure IKE
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Splint, Intranasal Septal LYA
    Mixer, Cement, For Clinical Use JDZ
    Stimulator, Electrical, Implantable, For Incontinence EZW
    Probe, Radiofrequency Lesion GXI
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence QON
    Sacroiliac Joint Fixation OUR
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Pin, Fixation, Smooth HTY
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Instrument, Shunt System Implantation GYK
    Dispenser, Cement KIH
    Filler, Bone Void, Calcium Compound MQV
    Bone Fixation Cerclage, Sublaminar OWI
    Posterior Cervical Screw System NKG
    Staple, Fixation, Bone JDR
    Guide, Surgical, Instrument FZX
    System, Image Processing, Radiological LLZ
    Bronchoscope Accessory KTI
    Hearing Aid, Bone Conduction LXB
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Elevator HTE
    Rod, Fixation, Intramedullary And Accessories HSB
    Esophageal Thermal Regulation And Gastric Suctioning Device PLA
    Temperature Regulation Device For Esophageal Protection During Cardiac Ablation QXV
    Ventilator, Continuous, Facility Use CBK
    Cannula, Injection FGY
    Osteotome, Manual GFI
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Rasp HTR
    Syringe, Piston FMF
    Arthroscope HRX
    Instrument, Manual, Surgical, General Use MDM
    Medical Device Data System OUG
    Prosthesis, Subtalar, Plug, Polymer MJW
    Aortic Annuloplasty Ring PST
    System, Tomography, Computed, Emission KPS
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Osteotome HWM
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Aid, Surgical, Viscoelastic LZP
    Bone Wedge PLF
    Absorbable Synthetic Wound Dressing QSZ
    Kit, Surgical Instrument, Disposable KDD
    System, Skin Closure MKY
    Template HWT
    Catheter, Retention Type, Balloon EZL
    Cerclage, Fixation JDQ
    Electrode, Needle GXZ
    Prosthesis, Wrist, Hemi-, Ulnar KXE
    Powered Laser Surgical Instrument GEX
    Tray, Surgical, Instrument FSM
    Table, Operating-Room, Ac-Powered FQO
    Instrument, Surgical, Non-Powered HAO
    Implanted Subcortical Electrical Stimulator (Motor Disorders) MRU
    Guide, Needle, Surgical GDF
    Orthopedic Computer Controlled Surgical System OJP
    Instruments, Surgical, Cardiovascular DWS
    Tap, Bone HWX
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Stimulator, Thalamic, Epilepsy, Implanted MBX
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Applicator, Ent KCJ
    Generator, Lesion, Radiofrequency GXD
    Orthopedic Manual Surgical Instrument LXH
    Accessories, Arthroscopic NBH
    Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence NAM
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Instrument, Bending Or Contouring HXP
    Dressing, Wound, Drug FRO
    Lavage, Jet FQH
    Handle, Scalpel GDZ
    Spatula, Orthopedic HXR
    Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation OIS
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    System, Test, Radioallergosorbent (Rast) Immunological DHB
    Crown, Preformed ELZ
    Bit, Drill HTW
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Stylet, Tracheal Tube BSR
    Shunt, Central Nervous System And Components JXG
    Prosthesis, Finger, Constrained, Polymer KYJ
    Catheter, Nasopharyngeal ENW
    System, Facet Screw Spinal Device MRW
    Impactor HWA
    Blade, Scalpel GES
    Extractor HWB
    Reamer HTO

    Proprietary Names

    BioPoly Lesser Toe Hemiarthroplasty Implant Internal/Single-stage Abutment Screw JUGGERSTITCH Klassic® Femur, Aurum® ALEUTIAN Cervical Klassic® Tibial Insert, PS-Max®, Std Poly Klassic® Femur, Revision Klassic® Tibial Insert, PS-Post®, E-Link MISC TRAUMA PERIARTICULAR Platform® Acetabular Cup with Ti-Coat® Platform® Neutral Acetabular Insert with E-Link® Platform® Hooded Acetabular Insert with E-Link® Adapter for BIOLOX® OPTION Femoral Head Klassic® Stem Extension, Femoral, Cemented Klassic® Stem Adapter, Femoral ALPS SMALL FRAG Apdyne Phenol Applicator Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)