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510(k) Data Aggregation

    K Number
    K063820
    Device Name
    LISFRANC PLATE
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2007-02-08

    (44 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Newdeal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometarsal joints (Lisfranc joints).
    Device Description
    The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
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    K Number
    K070160
    Device Name
    MODIFICATION TO TTC PLATES
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2007-02-08

    (22 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Newdeal TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle.
    Device Description
    The NEWDEAL® TTC Plates consists of a tibiotalocalcaneal plate, available in different sizes, dedicated to be fixed using NEWDEAL® locking system fixation screws and washers. It is available in different sizes, and is implanted using NEWDEAL® locking system fixation screws and washess. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates extemporaneously a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socked at the top of each hole, thus blocking each screw head.
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    K Number
    K070241
    Device Name
    MODIFICATION TO LAPIDUS PLATE
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2007-02-08

    (14 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
    Device Description
    The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1* tarsometatarsal joint, available in different sizes, which will be fixed using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking System includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single plate/screw unit fixed into the bone. The ostedsynthesis screws must be driven into the bone through the holes in the mo one. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
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    K Number
    K060474
    Device Name
    LISFRANC PLATE
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2006-08-03

    (161 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEWDEAL Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfranc joints)
    Device Description
    The NEWDEAL® Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints (Lisfranc joints). It is available in different sizes, and is implanted using screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
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    K Number
    K061765
    Device Name
    KALIX II IMPLANT
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2006-07-18

    (26 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KALIX® II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. - flat foot treatment in children and adolescents - congenital flat foot - non successful long term orthopaedic treatment (shoes, insoles ... ) - tarsal coalitions - painfully flat foot - supple deformity in posterior tibial tendon dysfunction - paralytic flat foot - subtalar instability.
    Device Description
    The KALIX® II Flat Foot implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This is the same indication for use as the Kalix® II Implant, K053093. The KALIX® II Flat Foot implant is a combination of three components. Two of them are made from Titanium alloy (Ti-6Al-4V) that conforms to both ISO 5832-3 and ASTM F136 standards. The outer sleeve is made from Ultra High Molecular Weight Polyethylene (UHMWPE) is an conforms to ASTM F648-00 standard. These are the same materials as the unmodified device, KALIX® II Flat Foot implant, K053093.
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    K Number
    K061594
    Device Name
    LARGE UNI-CLIP STAPLE
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2006-07-03

    (25 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LARGE UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery - Fractures management in the foot or hand - Mono or Bi-cortical osteotomies in the foot or hand - Distal or proximal metatarsal or metacarpal osteotomies - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) The size and number of staple(s) used should be adapted to the specific indication.
    Device Description
    The LARGE UNI-CLIP® STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of size. The LARGE UNI-CLIP® STAPLE is made from 316L Stainless Steel that conforms to ISO 5832-1 and ASTM F138 & F139 standards.
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    K Number
    K060473
    Device Name
    TTC PLATE
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2006-05-17

    (83 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEWDEAL® TTC Plates are intended for use in arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones including the foot and ankle.
    Device Description
    The NEWDEAL® TTC Plates consists of a plate, available in different sizes, and implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system creates a single implant/screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
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    K Number
    K060476
    Device Name
    LAPIDUS PLATE
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2006-05-17

    (83 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, - Lisfranc arthrodesis - - mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
    Device Description
    The NEWDEAL® Lapidus Plate consists of an osteosynthesis plate designed to bridge the 1st tarsometatarsal joint, available in different sizes, which are implanted using NEWDEAL® locking system fixation screws and washers. The NEWDEAL® locking system includes as many fixation screws as there are threaded lipped sockets on the plate and as many washers as implanted screws. The NEWDEAL® locking system oreates a single /screw unit fixed into the bone. The osteosynthesis screws must be driven into the bone through the holes in the plate. The system is locked by means of washers drilled into the threaded lipped socket at the top of each hole, thus blocking each screw head.
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    K Number
    K053093
    Device Name
    KALIX II IMPLANT, MODEL 141 0XX WITH XX
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2005-12-07

    (34 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KALIX II implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. - flat foot treatment in children and adolescents - - congenital flat foot - - non successful long term orthopaedic treatment (shoes, insoles ... ) - - tarsal coalitions - - painfully flat foot - - supple deformity in posterior tibial tendon dysfunction - - paralytic flat foot - - subtalar instability. -
    Device Description
    The KALIX® II Flat Foot implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. This is the same indication for use as the Kalix Implant, K001231.
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    K Number
    K052152
    Device Name
    B-BOP PLATE
    Manufacturer
    NEWDEAL S.A.
    Date Cleared
    2005-09-13

    (36 days)

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

    NEWDEAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The B-BOP® plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include: - Moderate to severe hallux valgus - Hallux varus
    Device Description
    Newdeal has developed a plate dedicated to the fixation of basal osteotomy of the 1st metatarsal by designing the B-BOP® plate which allow to meet at best the specifications of that kind of surgical procedure. Characteristics of the plate have taken into account all the requirements associated with basal osteotomy: - Plantar positioning to obtain the best stability and resistance and allowing to reduce bulk - Anatomical shape adapted to the plantar curve of the 1st metatarsal (pre-bent), available in right or left side and in two angulations (5° and 10°) for medium or large deformation. The B-BOP® plate is made from titanium alloy (Ti-6AI-4V ELI) and the part of the plate in contact with bone is sandblasted for a better adherence of the plate. Plates and screws are also available which are color-coded for ease of identification. Fixation of the plate is provided by four Snap-Off screws, already present with the HALL 0 -Fix system (cleared under K021626). With the B-BOP® plate, screws are available in 2 diameters (2.7mm and 3.0mm) and in a length range from 14mm to 26mm (2 mm increment). The screws are provided sterile with the B-BOP® plate.
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