BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHO DEVELOPMENT CORP.

    Reg #: 1722511 · FEI: 1000143502 · Expires 2026
    View on FDA
    Products
    54
    Proprietary Names
    84
    Establishment Types
    4
    Classifications
    54

    Registration Details

    Registration Name
    ORTHO DEVELOPMENT CORP.
    Registration Number
    1722511
    FEI Number
    1000143502
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12187 SOUTH BUSINESS PARK DR.
    City
    DRAPER
    State
    UT
    ZIP
    84020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K971435

    Owner / Operator

    Firm Name
    Ortho Development Corporation
    Operator Number
    9012515
    Address
    12187 South Business Park Drive, --
    City
    Draper
    State
    UT
    Postal Code
    84020
    Country
    US
    Correspondent
    Drew Weaver

    Products

    Device Name Product Code
    Bit, Drill HTW
    Passer, Wire, Orthopedic HXI
    Extractor HWB
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Curette, Surgical, General Use FZS
    Thoracolumbosacral Pedicle Screw System NKB
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Tray, Surgical, Instrument FSM
    Broach HTQ
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Spinal Vertebral Body Replacement Device MQP
    Forceps HTD
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Guard, Instrument LXZ
    Bender HXW
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Cutter, Surgical FZT
    Plate, Fixation, Bone HRS
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Driver, Prosthesis HWR
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Template HWT
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Tape, Measuring, Rulers And Calipers FTY
    Nail, Fixation, Bone JDS
    Awl HWJ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Bone Cement, Antibiotic MBB
    Tap, Bone HWX
    Probe HXB
    Screwdriver HXX
    Screw, Fixation, Bone HWC
    Clamp HXD
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Hammer, Surgical FZY
    Instrument, Compression HWN
    Reamer HTO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Rod, Fixation, Intramedullary And Accessories HSB
    Retractor GAD
    Bone Fixation Cerclage, Sublaminar OWI
    Handle, Scalpel GDZ
    Guide, Surgical, Instrument FZX
    Mallet HXL
    Punch, Surgical LRY
    Impactor HWA
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Balanced Knee System Porous Femoral Peg Drill Instrument Headloc Alumina and Zirconia Ceramic Heads Trivicta Legend All-Poly Cup Encompass® Cemented Hip Stem Encompass Cemented Hip System Primaloc Cementless Hip System Curette IBIS Pedical Screw System Ortho Development Balanced Knee Tibial Tray Pegged ODC B2 Bipolar Cup Balancecd Knee System Legend Acetabular Liners Headloc Zirconia Ceramic Heads Orthopedic Broach Vusion® CS Plus Vusion® TS/PS/CS Vusion® TS/PS Vusion PEEK VBR System Legend Primaloc Cemented Hip System Hemisphere Modular Cup Balanced Knee® System Balanced Knee System Ultracongruent Tibial Insert Alpine Cemented Hip System Encompass 10/12 Hip Stem TriMax Mode Trauma System Pivot Bipolar Head Vusion® OS Integrated® Spine System ISS Integrated Spine System Balanced Knee System High Flex PS BKS TriMax® Contour Spinal System Template Envision Anterior Cervical Plate System Envision® Anterior Cervical Plate System Tape, Measuring, Rulers and Calipers No brand name Tri-Plus Encompass Press-Fit Hip Stem Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella BKS E-Vitalize™ PS Tibial Insert, Vitamin E BKS E-Vitalize® KASM® Knee Articulating Spacer Mold Knee Articulating Spacer Molds KASM® Knee Articulating Spacer Mold Ortho Development Ceramic Femoral Heads Pisces Solitude® Unipolar Solitude Unipolar Head BKS® Revision Sleeves Encompass Press-Fit Hip Stem Ovation 10/12 Hip Stem Ovation® Hip Stem Balanced Knee System Uni Ortho Development Biolox Delta Ceramic Femoral Heads Alpine Hip Stem Alpine® Hip Stem Hemisphere Acetabular Cup Balanced Knee System Revision Offset Tibia Balanced Knee® Revision System Balanced Knee Modular Tibial System BKS Revision Headloc Ceramic Femoral Head VARIOUS TYPES OF REAMERS Ortho Development Balanced Knee System Venus Hip MODE Balanced Knee® System TriMax® CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts Escalade Legend Acetabular Shell BKS Revision Cones Ovation Hip Stem Ovation Tribute Hip Stem; Ovation Narrow Hip Stem Ovation Tribute® Hip Stem Retractor The Gecko Spinal System Ortho Development Ceramic Femoral Heads with Press-fit Stems Entrada Ibis Pedicle Screw System Escalade Acetabular Cup System Pagoda Pedicle Screw System Pagoda® Pedicle Screw VARIOUS TYPES OF ORTHOP

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only