BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRO-TECH Design & Mfg, Inc.

    Reg #: 3010531069 · FEI: 3010531069 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    29

    Registration Details

    Registration Name
    PRO-TECH Design & Mfg, Inc.
    Registration Number
    3010531069
    FEI Number
    3010531069
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4041 Express Street
    City
    Arlington
    State
    TX
    ZIP
    76001
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120029
    PMA Number
    P020056

    Owner / Operator

    Firm Name
    PRO-TECH Design & Mfg, Inc.
    Operator Number
    9048910
    Address
    14561 MARQUARDT AVE., --
    City
    Santa Fe Springs
    State
    CA
    Postal Code
    90670
    Country
    US

    Products

    Device Name Product Code
    Dorsal Root Ganglion Stimulator For Pain Relief PMP
    Kit, Surgical Instrument, Disposable KDD
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Set, Administration, Intravascular FPA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Thoracolumbosacral Pedicle Screw System NKB
    System, Suction, Lipoplasty MUU
    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled FTR
    Lavage, Jet FQH
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Prosthesis, Breast, Inflatable, Internal, Saline FWM
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Instruments, Surgical, Cardiovascular DWS
    Lipoaspirate Washing System For Aesthetic Body Contouring QKL
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    Hemiphalangeal Implant System Instruments, Surgical, Cardiovascular EPG Pouch with Adhesive

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device