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510(k) Data Aggregation

    K Number
    K081400
    Device Name
    FANNING-PAPPAS MODULAR KNEE BEARING
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    2009-02-20

    (277 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fenning-Pappas, Modular Knee Bearing is intended for reconstruction or revision of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis, in knees having coirectable mity, and viable or reconstructable ligaments. valgus or var ..
    Device Description
    Not Found
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    K Number
    K012702
    Device Name
    BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    2002-01-30

    (169 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BUECHEL-PAPPAS (B-P) Fixed Bearing New Jersey (NJ) Total Knee Replacement System is intended for the reconstruction of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Additionally, it is intended for Subjects with severe arthritis (e.g. Posttraumatic, rheumatoid or osteoarthritis.). with sufficient bone stock (i.e. cortical bone present to support the platform of the components) and ligamentous support (i.e. intact medial and lateral collateral ligaments) to allow stable, anatomical positioning of components and supporting tissue structures, who are skellatly mature and have not responded to conservative treatment (i.e. injections, therapy, etc.). Porous components and textured components are intended for cemented use.
    Device Description
    Buechel-Pappas (B-P) Fixed Bearing New Jersey Total Knee Replacement System
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    K Number
    K992394
    Device Name
    BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    1999-10-15

    (88 days)

    Product Code
    HSD
    Regulation Number
    888.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BUECHEL-PAPPAS™ Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Biocoat® porous coated components are intended for cemented use only.
    Device Description
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    K Number
    K982418
    Device Name
    BUECHEL-PAPPAS MODULAR SALVAGE STEM
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    1999-04-29

    (290 days)

    Product Code
    MJT, HSD, KWT
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BUECHEL-PAPPAS™ Modular Salvage Shoulder Replacement System is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis, rheumatiod arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis; for use in the absence of a functionally sufficient rotator cuff as well as where the proximal humerus is insufficient to support a standard angled humeral prosthesis. Biocoat® porous coated components are intended for cemented use.
    Device Description
    Not Found
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    K Number
    K963100
    Device Name
    TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    1997-02-12

    (187 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963101
    Device Name
    B-P HEMISPHERICAL ACETABULAR COMPONENT
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    1997-02-12

    (187 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960425
    Device Name
    BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    1996-10-03

    (248 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960424
    Device Name
    BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
    Manufacturer
    ENDOTEC, INC.
    Date Cleared
    1996-08-26

    (210 days)

    Product Code
    KWT
    Regulation Number
    888.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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