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510(k) Data Aggregation

    K Number
    K013572
    Device Name
    MITEK BIOCRYL INTERFERENCE SCREWS
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2002-03-14

    (136 days)

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

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mitek Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
    Device Description
    The device described in this 510(k) is sterile, disposable implant designed to secure soft tissue to bone. The Mitek Biocryl Interference Screws are indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
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    K Number
    K013781
    Device Name
    RIDIDFIX 2.7MM BTB CROSS PIN KIT
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2002-02-06

    (84 days)

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

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RigidFix™ 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial fixation of autograft or allograft ACL bone-tendon-bone (BTB) grafts.
    Device Description
    The device described in this 510(k) is a sterile, disposable, device designed for single patient use only. The cross pins are constructed of bioabsorbable Poly Lactic Acid (PLA).
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    K Number
    K002639
    Device Name
    BIOKNOTLESS ANCHOR
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2001-05-11

    (260 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder; Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle; Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot; Hallux Valgus reconstruction. Elbow; Tennis elbow repair, Biceps tendon reattachment. Knee; Extra capsular repairs, reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
    Device Description
    The device described in this 510(k) is a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The product is designed for single patient use only. The anchor is constructed of Polylactic Acid (PLA) and the Panacry)™ suture is a braided long term absorbable suture.
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    K Number
    K010633
    Device Name
    RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2001-05-09

    (68 days)

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

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).
    Device Description
    The device described in this 510(k) is a sterile, disposable device designed for single patient use only. The crosspins are constructed of bioabsorbable Poly L-lactic Acid (PLA).
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    K Number
    K002406
    Device Name
    MITEK 2GII MENISCAL REPAIR SYSTEM
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2001-02-15

    (192 days)

    Product Code
    MAI, GAM, GAS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).
    Device Description
    The Mitek RapidLoc™ Meniscal Repair System described in this 510(k) is a sterile, two I router Description: "Ho witting of a molded PLA Backstop and Tophat.
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    K Number
    K003076
    Device Name
    MITEK CUFFTACK
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2000-10-27

    (24 days)

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

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002402
    Device Name
    VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2000-08-31

    (24 days)

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

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002422
    Device Name
    VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2000-08-31

    (23 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000936
    Device Name
    VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    2000-04-19

    (27 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993575
    Device Name
    RESOLVE QUICKANCHOR
    Manufacturer
    MITEK PRODUCTS
    Date Cleared
    1999-12-29

    (69 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITEK PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReSolve ™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications: Cranio/Maxillofacial: Repair, reconstruction or reattachment of tendons, ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
    Device Description
    The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.
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