BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    UNITED ORTHOPEDIC CORPORATION

    Reg #: 3012329926 · FEI: 3012329926 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    91
    Establishment Types
    2
    Classifications
    32

    Registration Details

    Registration Name
    UNITED ORTHOPEDIC CORPORATION
    Registration Number
    3012329926
    FEI Number
    3012329926
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    57 Park Ave. 2, Science Park
    City
    Hsinchu
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K221675

    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
    Correspondent
    Jason - Lin

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

    Proprietary Names

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

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device