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510(k) Data Aggregation

    K Number
    K961555
    Device Name
    ACUFEX TAG BIOABSORBABLE ANCHORS
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Date Cleared
    1996-07-10

    (79 days)

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

    ACUFEX MICROSURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TAG® Bioabsorbable Anchors are intended to be used to secure suture to bone, thereby facilitating the reattachment of soft tissue. Indications The TAG® Bioabsorbable 3.7mm Rod, 3.7mm and 3.0mm Wedge Anchors statement are indicated for use in soft tissue to bone fixation in the surgical repair of injuries in the foot, ankle and elbow.
    Device Description
    The Acufex TAG Bioabsorbable Anchors are wedge-and rod shaped, sterile suture anchors, with a hole through which suture is threaded. the tag anchors are implanted into bone, burying and anchoring the implant and attached suture, which can be used to reattach and secure soft tissue, such as ligaments and tendons. Three sizes of the devices will be used in the foot, ankle and elbow applications, the Tag 3.7mm Wedge and Rod II and 3.0mm and 2.0mm Wedge Anchors.
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    K Number
    K961853
    Device Name
    PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Date Cleared
    1996-06-21

    (38 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUFEX MICROSURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fast Pass Suture Punch System is indicated for the placement of sutures in Rotator Cuff and Bankart repair procedures. The Fast Pass Suture Punch System is intended to be used for the placement of sutures during arthroscopic and open procedures.
    Device Description
    The Fast Pass Suture Punch System comprises three components: the Fast pass Suture Punch, the Fast Pass Suture Needle, and the Fast Pass Cannula/Obturator.
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    K Number
    K954246
    Device Name
    ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Date Cleared
    1996-02-15

    (157 days)

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

    ACUFEX MICROSURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952535
    Device Name
    ACUFEX ENDOBUTTON TAPE
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Date Cleared
    1996-02-08

    (252 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUFEX MICROSURGICAL, INC.

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

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