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510(k) Data Aggregation

    K Number
    K172349
    Device Name
    InFill® Interbody Fusion Device
    Manufacturer
    Pinnacle Spine Group, LLC
    Date Cleared
    2017-12-14

    (133 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pinnacle Spine Group, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.
    Device Description
    The InFill® Interbody Fusion Device product family consists of radiolucent implantable devices manufactured from PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced and contains tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® Interbody Fusion Device is provided sterile.
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    K Number
    K152259
    Device Name
    InFill Interbody Fusion Device
    Manufacturer
    Pinnacle Spine Group, LLC
    Date Cleared
    2015-11-19

    (100 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pinnacle Spine Group, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
    Device Description
    The InFill® V2 Lateral is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® V2 Lateral is provided sterile, for single use only.
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    K Number
    K151184
    Device Name
    InFill Interbody Fusion Devices
    Manufacturer
    PINNACLE SPINE GROUP, LLC
    Date Cleared
    2015-07-14

    (71 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINNACLE SPINE GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
    Device Description
    The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® interbody fusion device is provided sterile, for single use only.
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    K Number
    K150206
    Device Name
    InFill Interbody Fusion Devices
    Manufacturer
    PINNACLE SPINE GROUP, LLC
    Date Cleared
    2015-04-03

    (64 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINNACLE SPINE GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
    Device Description
    The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® interbody fusion device is provided sterile, for single use only.
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    K Number
    K143488
    Device Name
    InFill Graft Delivery System
    Manufacturer
    PINNACLE SPINE GROUP, LLC
    Date Cleared
    2014-12-17

    (9 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINNACLE SPINE GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.
    Device Description
    The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannulated applicator tip and accessories for mixing bone graft materials and filling of the system. The modified InFill™ Graft Delivery System is provided sterile, for single use only.
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    K Number
    K140066
    Device Name
    INFILL CERVICAL
    Manufacturer
    PINNACLE SPINE GROUP, LLC
    Date Cleared
    2014-05-05

    (115 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINNACLE SPINE GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InFill® cervical interbody fusion device is intervertebral body fusion of the spine in skeletally mature patients. The InFill® cervical interbody fusion device is designed for use with autogenous bone grafi to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with this device. The InFill® cervical interbody fusion device is intended to be used with supplemental internal fixation systems that are cleared by the FDA for use in the cervical spine.
    Device Description
    The InFill® Cervical Interbody Fusion device are radiolucent implantable devices manufactured from PEEK Optima LT1 and tantalum ASTM F560 (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® Cervical Interbody Fusion device is provided sterile, for single use only.
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    K Number
    K133721
    Device Name
    INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
    Manufacturer
    PINNACLE SPINE GROUP, LLC
    Date Cleared
    2014-03-31

    (116 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINNACLE SPINE GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
    Device Description
    The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are radiolucent implantable devices manufactured from PEEK and tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are provided sterile, for single use only.
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    K Number
    K124012
    Device Name
    INFILL OBLIQUE TLIF DEVICE
    Manufacturer
    PINNACLE SPINE GROUP, LLC
    Date Cleared
    2013-06-04

    (159 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINNACLE SPINE GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InFill™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to facilitate fusion. InFill™ TLIF Oblique is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ TLIF Oblique is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
    Device Description
    The InFill™ TLIF Oblique is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill™ TLIF Oblique is provided sterile, for single use only.
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    K Number
    K121476
    Device Name
    INFILL GRAFT DELIVERY SYSTEM
    Manufacturer
    PINNACLE SPINE GROUP, LLC
    Date Cleared
    2012-08-29

    (103 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINNACLE SPINE GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.
    Device Description
    The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannula applicator tip and two caps. The device is provided sterile, for single use only.
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    K Number
    K121733
    Device Name
    INFILL INTERVERTEBRAL BODY FUSION DEVICE
    Manufacturer
    PINNACLE SPINE GROUP, LLC
    Date Cleared
    2012-07-13

    (30 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    PINNACLE SPINE GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
    Device Description
    The InFill™ intervertebral body fusion device is a radiolucent implantable device The in in in - fine PEEK and tantalum (marker material). The implant is available in manatatored 110 11011 * 11011 * 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 The InFill™ intervertebral body fusion device is provided sterile, for single use only.
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