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510(k) Data Aggregation

    K Number
    K112197
    Device Name
    MEMOMETAL INTRA-MEDULLARY BONE FASTENER
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2011-11-17

    (108 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
    Device Description
    MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER new device designs are single-use bone fixation appliances intended to be permanently implanted. Intramedullary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.
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    K Number
    K101930
    Device Name
    MEMOMETAL NAVIS BONE PLATING SYSTEM
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2011-03-15

    (249 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navis® radius Plate is indicated for the fixation of fractures and osteotomies involving the distal radius.
    Device Description
    MEMOMETAL Navis® Bone Plating System is single use bone fixation appliances intended to be permanently implanted. They are designed with anatomical shape plates made of biocompatible titanium alloy. The Bone Plating System use 2.5 mm locking, unlocking screws and 1.8 mm smooth locking pegs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different lengths, widths, number of plate holes, left and right shapes.
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    K Number
    K102072
    Device Name
    MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2010-11-03

    (103 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication.
    Device Description
    MEMOMETAL implants are single-use bone fixation appliances intended to be permanently implanted. MEMOMETAL implants are available in 2 different designs: - Snap-off pin, smooth with a stop and a sharp self drilling tip - Notched with a T-shaped head.
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    K Number
    K093820
    Device Name
    SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2010-05-19

    (156 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Memometal Technologies' SubFix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing subtalar joint motion but blocking excessive pronation and the resulting sequela. The SubFix Arthroereisis Implants are intended for single use only.
    Device Description
    The Memometal Implant is a one-piece device made of medical grade Titanium Alloy, Ti6A14V. The implant is available in 5 sizes ranging from 6.5 mm to 11.5 in diameter. No new materials or processes are used in the development of this implant.
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    K Number
    K083447
    Device Name
    MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2009-02-06

    (77 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEMOMETAL ANCHORAGE® Bone Plate Systems are indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist and ankles, fingers and toes. The system may be used in both adults and pediatric patients.
    Device Description
    MEMOMETAL ANCHORAGE® Bone Plate Systems are single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made of biocompatible titanium. The Bone Plate Systems use either 3mm or 3,5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, lengths, number of plate holes and shape.
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    K Number
    K071941
    Device Name
    MEMOMETAL BONE ANCHORS
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2007-12-04

    (144 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEMOMETAL Micro ARIM® is indicated for - Hand: Ligament reconstruction - Ankle: Midfoot reconstruction - Foot: Hallux Valgus reconstruction - Wrist: Scapholunate Ligament reconstruction - Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence
    Device Description
    MEMOMETAL Micro ARIM® anchors are single-use bone fixation appliances intended to be permanently implanted. Micro ARIM® anchors made of shape memory nickel titanium alloy. MEMOMETAL Micro ARIM anchors can be used in 2 versions with USP2-0 to USP 4-0 sutures (1 or 2 needles) listed below: Anchors Micro ARIM® th. 1mm - Length 3,8mm polyester suture (K012201) Anchors Micro ARIM® th. 1mm - Length 3,8mm Fiberwire suture (K041589) MEMOMETAL Micro ARIM® Anchors adopt an opened position after introducing into bone which allows a permanent fixation, thus supporting a secure ligament restoration.
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    K Number
    K070598
    Device Name
    MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2007-07-26

    (146 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEMOMETAL INTRA MEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
    Device Description
    MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER are single-use bone fixation appliances intended to be permanently implanted. Intramedulary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.
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    K Number
    K070039
    Device Name
    MEMOMETAL FIXOS SCREWS
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2007-03-21

    (77 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
    Device Description
    MEMOMETAL FIXOS SCREWS are single-use bone fixation appliances intended to be permanently implanted. Screws are cannulated compressive screws made of titanium alloy (Ti - 6Al -4V ELI) and snap-off screws made of titanium alloy (alloy (Ti - 6Al -4V ELI)
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    K Number
    K070031
    Device Name
    MEMOMETAL MEMORY STAPLES
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2007-03-19

    (75 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEMOMETAL MEMORY STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
    Device Description
    MEMOMETAL MEMORY STAPLES are single-use bone fixation appliances intended to be permanently implanted. Memory staples are bipodal or quadripodal compression staples made of shape memory nickel titanium alloy.
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    K Number
    K070033
    Device Name
    MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2007-03-19

    (75 days)

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

    MEMOMETAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEMOMETAL varisation staple is intended to be implanted for fixation of small bone fractures or for small bone reconstruction. The MEMOMETAL varisation staple is indicated for Akin type osteotomy.
    Device Description
    MEMOMETAL varisation staple is a staple with two self drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface
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