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

    S-ROM ZTP UHMWPE ACETABULAR CUP

    K Number: K951726 · Decision Jun 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    33
    Review Days
    68

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    Basic Information

    Device Name
    S-ROM ZTP UHMWPE ACETABULAR CUP
    K Number
    K951726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Joint Medical Products Corp.
    Date Received
    April 14, 1995
    Decision Date
    June 21, 1995
    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

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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
    K954935 S-ROM FEMORAL HIP STEM - SIZE 14 X 8
    K944321 S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II
    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. →