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510(k) Data Aggregation

    K Number
    K030881
    Device Name
    AVANTA CARPAL FUSION PLATING SYSTEM
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2003-04-10

    (21 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
    Device Description
    The Avanta carpal fusion plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel.
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    K Number
    K021859
    Device Name
    WRIST IMPLANT
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2002-12-02

    (179 days)

    Product Code
    JWJ
    Regulation Number
    888.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
    Device Description
    The wrist implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the wrist.
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    K Number
    K023604
    Device Name
    MODIFICATION TO RADIAL HEAD IMPLANT
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2002-11-27

    (30 days)

    Product Code
    KWI
    Regulation Number
    888.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius: - Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with: - joint destruction or subluxation visible on x-ray . - resistance to conservative treatment . - Primary replacement after fracture of the radial head . - Symptomatic sequelae after radial head resection .
    Device Description
    The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
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    K Number
    K013629
    Device Name
    FINGER JOINT PROSTHESIS
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2002-01-25

    (81 days)

    Product Code
    KYJ, SUT
    Regulation Number
    888.3230
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.
    Device Description
    The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.
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    K Number
    K010847
    Device Name
    K'FIX
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2001-06-19

    (90 days)

    Product Code
    NDL
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011819
    Device Name
    RADIAL HEAD IMPLANT
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2001-06-19

    (8 days)

    Product Code
    KWI, ORI
    Regulation Number
    888.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius: - Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with: - joint destruction or subluxation visible on x-ray - resistance to conservative treatment - Primary replacement after fracture of the radial head - Symptomatic sequelae after radial head resection - Revision following failed radial head arthroplasty
    Device Description
    The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
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    K Number
    K003033
    Device Name
    SCAPHIX, STAPLE, FIXATION, BONE
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2001-05-30

    (244 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010786
    Device Name
    ULNAR HEAD IMPLANT
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2001-04-11

    (27 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002644
    Device Name
    RADIAL HEAD IMPLANT
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    2000-11-20

    (88 days)

    Product Code
    KWI
    Regulation Number
    888.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990596
    Device Name
    DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
    Manufacturer
    AVANTA ORTHOPAEDICS, INC.
    Date Cleared
    1999-04-29

    (64 days)

    Product Code
    HRS, ACC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVANTA ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include: - Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone, - Failed fracture fixation with or without bone graft, ● - Osteotomy and repair of distal radius malunion with or without bone graft. .
    Device Description
    The distal radius plate like the predicate device includes various size plates, right, left, small, large, accessories and instruments. The bone screws enable the plate to be coupled to bone by securing the screws for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
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