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510(k) Data Aggregation

    K Number
    K162864
    Device Name
    OsteoVation Impact
    Manufacturer
    Skeletal Kinetics, LLC.
    Date Cleared
    2017-01-13

    (92 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Skeletal Kinetics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteo Vation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.
    Device Description
    OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate. OsteoVation Impact is comprised of two working components: a calcium phosphate, a sodium phosphate (SPMA), carboxymethylcellulose powder, a sodium silicate, sodium phosphate (SPMA) solution, and a mixing system (mixing bowl, pestle and spatula). The two working components are packaged separately and are to be mixed together by the end user prior to implantation. OsteoVation Impact is offered in 3cc, 5cc, and 10cc sterile convenience kits. Each kit includes the two working components in combination with a mixing bowl, pestle, and spatula. It is sterilized using gamma radiation with a minimum dose of 25 kGy and a maximum dose of 50 kGy with a Sterility Assurance Level of 10-9.
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    K Number
    K132211
    Device Name
    SKAFFOLD NMX BONE VOID FILLER
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2014-08-04

    (384 days)

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

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SKaffold NMX is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SKaffold NMX is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    SKaffold NMX is a pre-mixed moldable and biocompatible putty/paste bone void filler. SKaffold NMX consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process. The 5 cc and 10 cc SKaffold NMX kits are provided sterile and are for single use only.
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    K Number
    K120354
    Device Name
    BETA-TCP GRANULES
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2013-03-21

    (409 days)

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

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Beta TCP Granules Bone Void Filler (BVF) is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta TCP Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Beta TCP Granules BVF will resorb and be replaced with bone during the healing process.
    Device Description
    Beta TCP Granules Bone Void Filler is composed of porous, osteoconductive, resorbable beta- tricalcium phosphate (B-TCP) granules for repair of bony defects. The single use Beta TCP Granules sterile kit contains: Calcium Phosphate granules contained in a plastic vial packaged within two industry standard peel pouches that provide a double sterile barrier.
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    K Number
    K112383
    Device Name
    CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2012-02-07

    (173 days)

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

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
    Device Description
    Callos ProModel Bone Void Filler is a moldable and biocompatible calcium phosphate/calcium sulphate composite bone void filler. The single-use Callos ProModel kit contains the necessary components for mixing of the bone void filler. The Callos ProModel sterile kit contains: Calcium Phosphate/Calcium Sulfate Powder, Dilute Sodium Silicate Liquid, a Mixing System (Mixer and Syringe) and a Cannula.
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    K Number
    K111538
    Device Name
    SKAFFOLD CIS
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2011-10-25

    (145 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CAAP (Calcium Apatite) Bone Wax is indicated to control the bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
    Device Description
    The single use CAAP (Calcium Apatite) Bone Wax sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, and a Mixing System (Mixing Bowl, Pestle and Spatula). CAAP Bone Wax is to be mixed immediately prior to use.
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    K Number
    K100986
    Device Name
    CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2010-07-20

    (102 days)

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

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Callos Bone Void Filler is indicated to the following indications: 1 . To fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. 2. To be used with autograft as a bone graft extender (i.e. extremities, and pelvis only). Callos resorbs and is replaced by bone during the healing process.
    Device Description
    Callos Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. The single-use Callos Kit contains the necessary components for mixing of the bone void filler. The Callos sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, and a Mixing System (Mixing Bowl, Pestle and Spatula).
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    K Number
    K051784
    Device Name
    OSTEOVATION CMF BONE VOID FILLER
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2005-07-20

    (19 days)

    Product Code
    GXP, FWP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsteoVation CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². OsteoVation CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeletaon, including fronto-orbital, malar, and mental areas.
    Device Description
    OsteoVation is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.
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    K Number
    K051123
    Device Name
    CALLOS IMPACT AND INJECT BONE VOID FILLER
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2005-06-03

    (31 days)

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

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    Callos is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.
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    K Number
    K042072
    Device Name
    CALLOS CMF BONE VOID FILLER
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2004-09-16

    (45 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Callos CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Callos CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeleton, including fronto-orbital, malar, and mental areas.
    Device Description
    Callos CMF Bone Void Filler is an impactable and moldable single use, biocompatible calcium phosphate bone void filler, that remodels and is replaced by bone during the healing process. Callos CMF is packaged in various kit sizes (3cc, 5cc, and 10cc).
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    K Number
    K030554
    Device Name
    CALLOS
    Manufacturer
    SKELETAL KINETICS, LLC
    Date Cleared
    2003-05-20

    (88 days)

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

    SKELETAL KINETICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.
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