BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UOC USA Inc.

    Reg #: 3009760038 · FEI: 3009760038 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    91
    Establishment Types
    2
    Classifications
    32

    Registration Details

    Registration Name
    UOC USA Inc.
    Registration Number
    3009760038
    FEI Number
    3009760038
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    16601 Hale Ave
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183312

    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

    Products

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

    Proprietary Names

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

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device