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510(k) Data Aggregation

    K Number
    K100604
    Device Name
    OTIS -C PLUS
    Manufacturer
    SCIENCES ET BIO MATERIAUX (SBM)
    Date Cleared
    2010-06-14

    (103 days)

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

    SCIENCES ET BIO MATERIAUX (SBM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.
    Device Description
    The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTTS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The selftapping OTIS-C Plus screws allows easy and reliable one step locking, without counternut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.
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    K Number
    K021963
    Device Name
    BIOSORB RESORBABLE VOID FILLER
    Manufacturer
    SCIENCES ET BIO MATERIAUX (SBM)
    Date Cleared
    2003-01-28

    (228 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENCES ET BIO MATERIAUX (SBM)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOSORB® Resorbable Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB® Resorbable Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.
    Device Description
    BIOSORB® is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (ßTCP) indicated for Bone Void Filling. BIOSORB® implants are available in various shapes and sizes in order to fill various bone defect. Shapes are basic such as granules, cylinders, blocks and cubes. BIOSORB® presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB® implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of BIOSORB® resorbable void filler is intended to prevent premature resorption.
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