BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SSA HIP PROSTHESIS

    K Number: K840357 · Decision Feb 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    31
    Review Days
    22

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SSA HIP PROSTHESIS
    K Number
    K840357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    January 26, 1984
    Decision Date
    February 17, 1984
    Product Code
    JDI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JDI), ordered by most recent decision date.

    Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stryker Orthopaedics Hip Systems Labeling Update

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Global Modular Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Dow Corning Corp. Healthcare Industries Materials

    K Number Device Name
    K853186 SILASTIC INFLATABLE BONE PLUG H.P.
    K844637 WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
    K850255 DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
    K843995 TF-II HIP PROSTHESIS
    K842559 WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
    K831479 METAL-BACKED ACETABULAR CUP
    K812864 SILASTIC VOICE PROSTHESIS
    K812053 SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
    K811679 SILASTIC TENDON PASSER H.P.
    K801175 SILASTIC II MAMMARY IMPLANT
    Search all 31 clearances from Dow Corning Corp. Healthcare Industries Materials →