LogoFDA 510(k) Search
Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K212545
    Device Name
    FlexitSystem Knee osteotomy system
    Manufacturer
    Neosteo
    Date Cleared
    2022-02-11

    (183 days)

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

    Neosteo

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.
    Device Description
    The FlexitSystem® Knee osteotomy system range consists of metallic surgical devices intended to maintain opening and closing wedge osteotomies of the proximal tibia and distal femur. They are available in several lengths and shapes. A FlexitSystem® Knee osteotomy system consists of: -A Neosteo plate; -Neosteo screws that are locked into the plate. All the implants are made of titanium alloy. Fixation of the plate is ensured by the threading of the holes in the plate and the corresponding threads on the screws for a complete fixation of the implant.
    Ask a Question

    Ask a specific question about this device

    K Number
    K192447
    Device Name
    Superelastic Staple
    Manufacturer
    Neosteo
    Date Cleared
    2020-02-28

    (175 days)

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

    Neosteo

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Superelastic Staple are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
    Device Description
    The Superelastic Staple consists of staples available in several lengths. All the implants are made of NiTi alloy.
    Ask a Question

    Ask a specific question about this device

    K Number
    K191424
    Device Name
    Interphalangeal Joint Fusion Device Range
    Manufacturer
    Neosteo
    Date Cleared
    2019-08-28

    (91 days)

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

    Neosteo

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
    Device Description
    The Interphalangeal Joint Fusion Device Range consists of metallic devices intended to stabilize two bone fragments until bone fusion. They are available in several lengths and angulations. All the implants are made of titanium alloy.
    Ask a Question

    Ask a specific question about this device

    K Number
    K153182
    Device Name
    SELF- COMPRESSIVE SCREW
    Manufacturer
    NEOSTEO
    Date Cleared
    2015-11-25

    (22 days)

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

    NEOSTEO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Self-Compressive Screws are intended for the fixation of bone reconstruction in the hand and in forefoot surgery.
    Device Description
    The Self-Compressive Screw consists of screws available in several diameters and lengths. All the implants are made of titanium alloy. The fixation is provided thanks to the threading of the screw, which allows compression.
    Ask a Question

    Ask a specific question about this device

    K Number
    K150772
    Device Name
    Snap-Off Self-Compressive Screw
    Manufacturer
    NEOSTEO
    Date Cleared
    2015-05-08

    (45 days)

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

    NEOSTEO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Snap-Off Self-Compressive Screws are intended for the fixation of bone reconstruction in forefoot surgery. The Snap-Off Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.
    Device Description
    The Snap-Off Self-Compressive Screw consists of screws available in several lengths. All the implants are made of titanium alloy. The fixation is provided thanks to the threading of the screw, which allows compression.
    Ask a Question

    Ask a specific question about this device

    K Number
    K131471
    Device Name
    SELF-COMPRESSIVE SCREW
    Manufacturer
    NEOSTEO
    Date Cleared
    2013-08-28

    (98 days)

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

    NEOSTEO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.
    Device Description
    The Self-Compressive Screw consists of screws available in several diameters and lengths. All the implants are made of titanium alloy. The fixation is provided thanks to the threading of the screw, which allows compression.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1