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    FDA Registration Active 🇺🇸 United States

    Paragon Medical - Dayton

    Reg #: 1000200989 · FEI: 1000200989 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    37

    Registration Details

    Registration Name
    Paragon Medical - Dayton
    Registration Number
    1000200989
    FEI Number
    1000200989
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4201 Little York Rd
    City
    Dayton
    State
    OH
    ZIP
    45414
    Country
    US

    Owner / Operator

    Firm Name
    Paragon Medical Inc.
    Operator Number
    10043017
    Address
    8 Matchett Dr.
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Stephane - Langlois

    Products

    Device Name Product Code
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Template HWT
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Starter, Bone Screw HWD
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Motor, Drill, Pneumatic HBB
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    System, Facet Screw Spinal Device MRW
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Thoracolumbosacral Pedicle Screw System NKB
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Stimulator, Nerve ETN
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Spinal Vertebral Body Replacement Device MQP
    Prosthesis, Intervertebral Disc MJO
    Guide, Surgical, Instrument FZX
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Broach HTQ

    Proprietary Names

    Template NG COMPLETE KNEE SOLUTION ROTATING HINGE KNEE INSTRUMENT NG ROTATING HINGE KNEE FEMORAL AUGUMENT PROVISIONALS BASE NO. 5987 MISCELLANEOUS LEGACY CLASS I EXEMPT KNEE ITEMS NG ROTATING HINGE KNEE SIZE B FEMORAL INSTRUMENTS "BASE NO. 5881, 5987" NG COMPLETE KNEE SOLUTION ROTATING HINGE KNEE (RHK) INSTRUMENT Zimmer Trabecular Metal Total Ankle None PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER LCCK Instruments NexGen Complete Knee Solution PERSONA Zimmer Persona Personalized Knee System NexGen Complete Knee Solution - Rotating Hinge Knee SEG RHK KN INSTRUMENTS NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Persona Revision Knee System ADVANCE® SULCUS RESECTION ZIMMER KNEE JOINT REPLACEMENT PROSTHESES-MR LABELING

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)