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

    S-ROM FEMORAL HIP STEM - SIZE 14 X 8

    K Number: K954935 · Decision Jan 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    33
    Review Days
    87

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    Basic Information

    Device Name
    S-ROM FEMORAL HIP STEM - SIZE 14 X 8
    K Number
    K954935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Joint Medical Products Corp.
    Date Received
    October 27, 1995
    Decision Date
    January 22, 1996
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    Other Clearances by Joint Medical Products Corp.

    K Number Device Name
    K955511 ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
    K944321 S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II
    K951726 S-ROM ZTP UHMWPE ACETABULAR CUP
    K951084 S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS
    K951000 ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
    K941769 KNEE PROTHESIS
    K936037 S-ROM NOILES CRUCIATE RETAINING KNEE
    K934412 COATED ZT PROXIMAL SLEEVE
    K931676 S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG
    K935078 S-ROM TOTAL HIP REPLACEMENT SYSTEM
    Search all 33 clearances from Joint Medical Products Corp. →