BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PARAGON 28

    Reg #: 3008650117 · FEI: 3008650117 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    106
    Establishment Types
    4
    Classifications
    50

    Registration Details

    Registration Name
    PARAGON 28
    Registration Number
    3008650117
    FEI Number
    3008650117
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14445 Grasslands Dr.
    City
    Englewood
    State
    CO
    ZIP
    80112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183011
    PMA Number
    H200001

    Owner / Operator

    Firm Name
    Paragon 28
    Operator Number
    10033376
    Address
    14445 Grasslands Dr.
    City
    Englewood
    State
    CO
    Postal Code
    80112
    Country
    US
    Correspondent
    Tina O'Brien

    Products

    Device Name Product Code
    Rongeur HTX
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Washer, Bolt Nut HTN
    Impactor HWA
    Hook, Bone KIK
    Pin, Fixation, Smooth HTY
    Rasp HTR
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Bur, Surgical, General & Plastic Surgery GFF
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Passer, Wire, Orthopedic HXI
    Osteotome HWM
    Chisel, Surgical, Manual FZO
    Saw, Powered, And Accessories HAB
    Screwdriver HXX
    Needle, Aspiration And Injection, Disposable GAA
    Forceps HTD
    Orthopaedic Surgical Planning And Instrument Guides PBF
    Tamp HXG
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Filler, Bone Void, Calcium Compound MQV
    Syringe, Piston FMF
    Bone Wedge PLF
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Retractor GAD
    Bit, Drill HTW
    Template HWT
    Staple, Fixation, Bone JDR
    Extractor HWB
    Reamer HTO
    Rod, Fixation, Intramedullary And Accessories HSB
    Ankle Arthroplasty Implantation System OYK
    Instrument, Compression HWN
    Gauge, Depth HTJ
    Stylet, Surgical, General & Plastic Surgery GAH
    Curette HTF
    Set, Administration, Intravascular FPA
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Orthopedic Manual Surgical Instrument LXH
    Trephine HWK
    Countersink HWW
    Prosthesis, Total Talus Replacement, Metal QNN
    Tap, Bone HWX
    Guide, Surgical, Instrument FZX
    Instrument, Cutting, Orthopedic HTZ
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Tray, Surgical, Instrument FSM
    Bender HXW

    Proprietary Names

    Rongeur Additive Orthopaedics Patient Specific 3D Locking Lattice Screws Additive Orthopaedics Patient Specific 3D Locking Lattice Plates axIOLink PCFD Tether System R3ACT Stabilization System Impactor Bone Hook Phantom Metatarsal Shortening System Gorilla SMO Plating System Rasp HammerTube System Monkey Rings External Fixation System Precision MIS Bunion System Grappler Suture Anchor System TenoTac Soft Tissue Fixation System TenoTac 2 Soft Tissue Fixation System PROMO Triplanar Hallux Valgus Correction System Gorilla Plating System Gorilla HEvans Plate Baby Gorilla Plating System BOW & ARROW Plates Baby Gorilla/Gorilla Plating System Gorilla R3CON Plating System Gorilla TUFFNEK Screw System R3LEASE Stabilization System Paratrooper Plantar Plate Repair System Passer K-Wire Olive Wire Guide Wire Osteotome FJ-2000 Driver Bone Marrow Harvest Needle Forceps Patient Specific Marking Guides Monkey Bars™ Pin to Bar External Fixation System Tamp BEAST Demineralized Bone Matrix BEAST PLUS BEAST Injectable Putty Mgnum Bone Void Filler (BVF) Mixing and Delivery System Titan 3-D Wedge System Mgnum Bone Void Filler (BVF) Grappler Suture Anchor Extraosseous Crosswire System Grappler Suture Anchor R3INFORCE System Gorilla Ankle Fracture Plating System SILVERBACK Plating System Paragon 28 Custom Made Devices San Gio™ Baby Bennetts Additive Orthopaedics Locking Lattice Plate Additive Orthopaedics Locking Lattice Screw Drill bit Grappler Interference Screw System Template JAWS Nitinol Staple System Extractor Joust Beaming Screw System Monster Screw System Monster BITE Screw System PRECISION Jones Fracture System Reamer Phantom® Fibula Nail System Additive Orthopaedics Bone Wedge System MAVEN PSI MAVEN Patient-Specific Instrumentation System Compressor Distractor Gorilla Central Column Fusion Plating System Depth Gauge Surgical instrument cleaning brush/tool APEX 3D Total Ankle Replacement System The Brachiator Mini External Fixation System Curette Additive Orthopaedics Hammertoe Correction System Blunt Needle Phantom Small Bone Intramedullary Nail System Actuation Driver Trial Monkey Bars Pin to Bar External Fixation System Trephine Phantom® Hindfoot TTC/TC Nail System Baby Gorilla®/Gorilla® Plating System Countersink Monkey Rings External Ring Fixation System APEX 3D S Total Ankle Replacement System Additive Orthopaedics Patient Specific 3d Printed Bone Segments Patient Specific Talus Spacer Tap R3FLEX Stabilization System Drill Guide Tissue Protector Bun-Yo-Matic Spider Monkey Bone Transport System Phantom Hindfoot TTC/TC Nail System Additive Orthopaedics Bunion System Weil Kit Bone Planer JAWS™ Nitinol Staple System JAWS™ Great White™ Staple System Surgical Instrument motos and accessories/attachments Phantom ActivCore Nail System Tray Caddy Case Plate Bender

    Establishment Types

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