BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Smith and Nephew Operations Sdn. Bhd

    Reg #: 3022142628 · FEI: 3022142628 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    61
    Establishment Types
    1
    Classifications
    21

    Registration Details

    Registration Name
    Smith and Nephew Operations Sdn. Bhd
    Registration Number
    3022142628
    FEI Number
    3022142628
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PMT 797, Persiaran Cassia Selatan 8, Taman Perindustrian Batu Kawan, Bandar Cassia
    City
    Penang Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K201918

    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
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Washer, Bolt, Nut, Non-Spinal, Metallic NDG
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Washer, Bolt Nut HTN
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Pin, Fixation, Smooth HTY
    Device, Fixation, Proximal Femoral, Implant JDO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Toe, Constrained, Polymer KWH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ

    Proprietary Names

    EVOS R3 GENESIS LEGION OXINIUM TC-100 SCREW AND PLATING SYSTEM CONQUEST FN CANNULATED SCREWS PERI-LOC PERIARTICULAR AND VARIABLE- ANGLE LOCKED PLATING (VLP) SYSTEMS EVOS PLATING SYSTEMS D-RAD PLATING SYSTEM CHS COMPRESSION HIP SCREW CANNULATED SCREWS CHS COMPRESSION HIP SCREW CONQUEST FN D-RAD PLATING SYSTEM EVOS PLATING SYSTEM REFLECTION SYNERGY GENESIS II ANTHEM TC-100 PERI-LOC 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 42MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 40MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 48MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 42MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 32MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 38MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 38MM 4MM CANNULATED CAPTURED SCREW 34MM Stainless Stee 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 44MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 48MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 34MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 46MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 46MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 44MM 4MM CANNULATED CAPTURED SCREW 38MM Stainless Steel 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 36MM 4MM CANNULATED CAPTURED SCREW 32MM Stainless Steel 4MM CANNULATED CAPTURED SCREW 42MM Stainless Steel 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 36MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 30MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 32MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 34MM 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 50MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 50MM 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 40MM 4MM CANNULATED CAPTURED SCREW 44MM Stainless Steel 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 30MM Genesis Uni Knee System JOURNEY Uni Knee System JOURNEY II XR Bi-Cruciate Retaining Knee System JOURNEY II Uni Knee System JOURNEY PFJ System JOURNEY II CR Knee System JOURNEY BCS and II Knee Systems Legion Hinge Total ANTHEM Total Knee System Journey II UK Knee System Smith & Nephew Hip Systems ORTHOMATCH GENESIS II KNEE SYSTEM LEGION KNEE SYSTEM PROFIX KNEE SYSTEM

    Establishment Types

    Manufacture Medical Device