BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    UNITED ORTHOPEDIC CORP.

    Reg #: 9681642 · FEI: 1000395711 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    91
    Establishment Types
    3
    Classifications
    32

    Registration Details

    Registration Name
    UNITED ORTHOPEDIC CORP.
    Registration Number
    9681642
    FEI Number
    1000395711
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 16, Luke 1st Rd. Luzhu Dist.,
    City
    Kaohsiung
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K221705

    Owner / Operator

    Firm Name
    UNITED ORTHOPEDIC CORPORATION
    Operator Number
    9025838
    Address
    57 Park Ave. 2, Science Park
    City
    Hsinchu
    State
    TW-HSQ
    Postal Code
    TW NOTA300
    Country
    TW

    US Agent

    Business Name
    UOC USA INC.
    Contact Name
    Calvin Lin
    Address
    16601 Hale Ave
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US
    Email
    [email protected]
    Phone
    949 3283366

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Spinal Vertebral Body Replacement Device MQP
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Reamer HTO
    Orthopedic Manual Surgical Instrument LXH
    Gauge, Depth HTJ
    Impactor HWA
    Bender HXW
    Punch, Femoral Neck HWP
    Plate, Fixation, Bone HRS
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Interlaminal KWP
    Driver, Prosthesis HWR
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Bit, Drill HTW
    Table, Surgical With Orthopedic Accessories, Ac-Powered JEA
    Template HWT
    Orthosis, Spinal Pedicle Fixation MNI
    Tray, Surgical, Instrument FSM
    Extractor HWB
    Wrench HXC
    Caliper KTZ

    Proprietary Names

    U2 Total Knee System-PF+ U2 Total Knee System, XPE Tibial Insert, PS PLUS USTAR II System extension line U1 Bipolar System U1 Hip System - Bipolar UTF Stem U2 Hip Stem, Ti Porous Coated, Matrix VERTE-SPAN (LIFT VB SPINAL SYSTEM) UNITED Ceramic Femoral Head, Delta, 36 mm UTS Stem U2 Acetabular Cup UNITED Femoral Head UNITED U2 XPE Total Knee System Ultracongruent Insert UNITED U2 Acetabular Cup, Plasma Spray U-Motion II Acetabular Cup E-XPE Acetabular Components U-motion II Acetabular System- Additional Sizes reamer United Instruments U2 Total Knee System-PSA Type All Poly Tibial Component U2 femoral head Conformity Stem Conformity Stem, Coxa Vara, Collared Conformity Stem, High Offset Conformity Stem, Short Neck, Collared gauge U2 Femoral Component, CR, Cemented UTF Stem-Reduced impactor UNITED U2 Hip System UNITED Revision Hip Stem: UCP Stem Bender punch RECONSTRUCTION PLATE SYSTEM Uknee Total Knee System UNITED U2 Bipolar Implant 22mm Femoral Head U2 Bipolar Implant BONE GRAFT WASHER PF+ Patella TENOR SPINAL SYSTEM Conformity Stem Extension line Atlantis Cervical Plate (ACPII ANTERIOR CERVICAL PLATE SYSTEM) driver UNITED U2 Acetabular Component USTAR II Knee System USTAR II Hip System U2 Femoral Component, CR, Porous Coated, Intermediate Sizes Cellbrick Knee Spacer United U2 Total Knee System, PSA Type UNITED U2 Total Knee System, Femoral Component, PS type, #7 Conformity stem, cemented U2 Total Knee System E-XPE Products U2 Femoral Component, CR, Porous Coated U2 Total Knee System-Intermediate Sizes U2 Tibial Baseplate- CMA type U-Motion II Acetabular System Drill UNITED Femoral Heads, +2.5 and +7.5 offset U-Motion II Acetabular Components U1 Hip System UTF Stem, reduced, #0, #00 U2 Hip stem Resolve Modular Revision Hip Stem U2 Total Knee System - PSA Type extension line United DA Power Hook Orthopedic Implant Trials United U2 femoral head, 22mm delta ceramic head CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) VERTEX RECONSTRUCTION SYSTEM U2 Total Knee System, PSA Tibial Insert U2 Total Knee System, #0 Tray U-Motion II Acetabular System—Extension line UNITED Patella component Augment and Screw, PSA Type Conformity Stem Extension Line, #0 extractor EQUATION FIXATION SYSTEM Locking Cage Full XPE Cup wrench UNITED Ceramic Femoral Head, Forte and Delta United U2 Total Knee System, PSA Type, Stem UTF Stem, reduced, #1~#11 Caliper U2 Total Knee System TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)