BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Orthopedic Designs North America, Inc.

    Reg #: 1064129 · FEI: 3002684506 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    80
    Establishment Types
    1
    Classifications
    15

    Registration Details

    Registration Name
    Orthopedic Designs North America, Inc.
    Registration Number
    1064129
    FEI Number
    3002684506
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5912 Breckenridge Parkway, Suite F
    City
    Tampa
    State
    FL
    ZIP
    33610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210146

    Owner / Operator

    Firm Name
    Orthopedic Designs North America, Inc.
    Operator Number
    10031399
    Address
    5912 Breckenridge Parkway, Suite F
    City
    Tampa
    State
    FL
    Postal Code
    33610
    Country
    US
    Correspondent
    Robin A Wilson

    Products

    Device Name Product Code
    Instrument, Compression HWN
    Gauge, Depth HTJ
    Screw, Fixation, Bone HWC
    Awl HWJ
    Nail, Fixation, Bone JDS
    Template HWT
    Rod, Fixation, Intramedullary And Accessories HSB
    Reamer HTO
    Tap, Bone HWX
    Impactor HWA
    Washer, Bolt Nut HTN
    Bit, Drill HTW
    Orthopedic Manual Surgical Instrument LXH
    Wrench HXC
    Tray, Surgical, Instrument FSM

    Proprietary Names

    Compression Sleeve Compressor Depth Gauge Screw Depth Gauge Lag Guide Pin Depth Gauge Cannulated Compression Device System Awl Curved Entry Awl ODI Talon Intramedullary Hip Nail Radiographic Talon Template Folding Nail Guide Wire Ruler Radiographic Ruler Guide Arm Guide Wire Ruler ODI Talon Long Prox Fem Nail Sys Proximal Reamer Modular Reamer Cutter Head Modular Flexible Reamer Shaft Entry Reamer 6.1mm Reamer 7.5mm Tap Impactor Extractor Impactor / Extractor ODI Ultimate Compression Hip Screw ODI 7mm Cannulated Screw System Cortical Drill Talon DistalFix Proximal Femoral Nail Atlas™ Humeral Nail System Talon DistalFix Humeral Nail Lag Driver Guide Wire Introducer Hex Driver 5 & 7mm Tissue Protector Guide Wire Pusher Ball Tip Sheathed Guide Wire (600mm & 900mm) Lag Driver Connector Screw Lag Alignment Plug Lag Talon Retractor Driver T-Handle Pin Puller Lag Guide Pin Obturator Ratcheting Axial Handle Torque Limiting Handle Nail Talon Driver Lag Drill Lag Talon Deployment Driver Lag Guide Sleeve Slotted Slap Hammer Lag Drill Stop Exchange Tube Lag Guide Pin (550mm & 800mm) Guide Wire Obturator Guide Wires (Trocar, Threaded, Round, Ball Tip - 280mm, 500mm, 600mm & 900mm) Drill Sleeve Guide Handle Slide Hammer Nail-Handle Connector Screw Screw Sleeve T25 Driver Trocar Handle-Arm Connector Screw Talon Driver Driver Connector Screw Retractor Driver Handle-Arm Screw Dual End Drill Guide Driver Shaft Guide Arm Lock Flex Anchor Retraction Driver Flex Anchor Deployment Driver Compression Nut Driver Palm Grip Axial Handle Lag Guide Pin Placement Aid Knob Wrench Talon DistalFix A/R Femoral Nail Instrument Tray Talon DistalFix Humeral Nail Instrument Tray Talon DistalFix Nail Instrument Tray Talon DistalFix Removal Tray CCD Instrument Tray Talon DistalFix Antegrade/Retrograde Femoral Nail

    Establishment Types

    Manufacture Medical Device