BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RASP CURVED DOWN

    Reg #: 1219602 · FEI: 1219602 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1219602
    FEI Number
    1219602
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENDOSCOPY, 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD.
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K940985

    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
    Arthroscope HRX

    Proprietary Names

    RASP CURVED DOWN SMALL JOINT PROBE CURRETTE OPEN 4MM (curette, probe, rasp, osteotome ) RASP STRAIGHT GOUGE COMPOUND CURVE SMALL JOINT OPEN CURETTE CHONDRAL PICK, LARGE SHAFT 40 DEGREE NON-CANNILATED HANDLE TIBIAL RASP 6.4 MM STRAIGHT GOUGE RASP CONVEX CHONDRAL PICK, LARGE SHAFT 20 DEGREE PCL TIBIAL CURETTE, CLOSED CHONDRAL PICK, SMALL SHAFT 20 DEGREE Small Joint Arthroplasty System RASP COMPOUND CURVE OSTEOTOME STRAIGHT SMALL JOINT CLOSED CURETTE PCL TIBIAL HOOK KNIFE PCL TIBIAL CURETTE, OPEN CURETTE OPEN 7MM SMALL JOINT OSTEOTOME GOUGE NOTCHPLASTY CURVED 6.4MM ACL CHAMFERING RASP CHAMFERING CHONDRAL PICK, SMALL SHAFT 40 DEGREE ACL CHAMFERING RASP 7 MM, HALF-ROUND ACL CHAMFERING RASP 8 MM, HALF-ROUND ACL CHAMFERING RASP BONE TUNNEL PCL FEMORAL CURETTE, CALIBRATED CURETTE CLOSED 5MM CURETTE CLOSED 3MM

    Establishment Types

    Manufacture Medical Device