BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMITH & NEPHEW, INC.

    Reg #: 3005551626 · FEI: 3005551626 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    14

    Registration Details

    Registration Name
    SMITH & NEPHEW, INC.
    Registration Number
    3005551626
    FEI Number
    3005551626
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6409 E Holmes Rd
    City
    Memphis
    State
    TN
    ZIP
    38141
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161233

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO

    Proprietary Names

    OXINIUM DH PATELLO-FEMORAL KNEE PROSTHESIS LEGION GENESIS II OXINIUM PROFIX OXINIUM OR3O Dual Mobility Liners JOURNEY JOURNEY II Unicompartmental Knee System OXINIUM ANTHOLOGY ANTHOLOGY HIP SYSTEM OXINIUM FEMORAL HEAD SPECTRON HIP SYSTEM SYNERGY HIP SYSTEM REFLECTION GENESIS GENESIS KNEE SYSTEM JOURNEY KNEE SYSTEM OR30 OR3O Dual Mobility System DEUCE PROFIX R3 Acetabular System CPCS Hip Stems Femoral Heads Anthology Hip Stems Synergy Hip Stems Spectron Hip Stems HYBRID KNEE PROSTHESIS R3 GENESIS II KNEE SYSTEM LEGION KNEE SYSTEM PROFIX KNEE SYSTEM

    Establishment Types

    Manufacture Medical Device