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510(k) Data Aggregation

    K Number
    K152077
    Device Name
    MaxiGen
    Manufacturer
    HANS BIOMED CORP.
    Date Cleared
    2016-04-21

    (269 days)

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

    HANS BIOMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MaxiGen™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process
    Device Description
    MaxiGen™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with calcium sulfate and carboxymethylcellulose (CMC). MaxiGen™ comes in the form of a kit with a premeasured and premixed DBM, calcium sulfate, and CMC powder, premeasured mixing solution, the tools for mixing the components, and a 5cc syringe. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids, or it can be injected using the syringe supplied in the kit. This product is supplied sterile for permanent resorbable device, implanted in bone tissue.
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    K Number
    K151271
    Device Name
    BellaFuse
    Manufacturer
    Hans Biomed Corp.
    Date Cleared
    2016-03-11

    (303 days)

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

    Hans Biomed Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BellaFuse™ is an implant intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bellafuse™ resorbs and is replaced with bone during the healing process.
    Device Description
    Device Identification and Materials of Use: BellaFuse™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with gelatin. The primary component of this BVF product is demineralized particle bone, which is derived from human donor cortical bone. The additional porcine gelatin is a biocompatible component which maintains the shape and enhances flexibility. Device Characteristics: This product is provided in several flexible sheet sizes ranging from 10x10x2.5mm to 50x100x5.0mm. It is supplied sterile for single patient use. Body Contact: BellaFuse™ is a permanent resorbable device, implanted in bone tissue.
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    K Number
    K130235
    Device Name
    SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
    Manufacturer
    HANS BIOMED CORP.
    Date Cleared
    2014-01-10

    (345 days)

    Product Code
    NUN
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANS BIOMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurFuse ™ II Putty and ExFuse ™ II Putty are bone filling materials indicated for dental intraosseous, oral and maxillofacial defects, including periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects.
    Device Description
    The SurFuse ™ II Putty and ExFuse ™ II Putty are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty-like consistency. The ExFuse ™ II Putty also contains cancellous bone powder. They are provided sterile for single patient use. The products are provided sterile for single patient use.
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    K Number
    K113728
    Device Name
    SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
    Manufacturer
    HANS BIOMED CORP.
    Date Cleared
    2012-11-15

    (332 days)

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

    HANS BIOMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
    Device Description
    The SurFuse™ and ExFuse™ family of products are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty or gel-like consistency. The ExFuse™ products also contain cancellous bone powder. The products are provided sterile for single patient use.
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