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510(k) Data Aggregation

    K Number
    K092540
    Device Name
    C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
    Manufacturer
    RSB SPINE LLC.
    Date Cleared
    2010-01-27

    (161 days)

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

    RSB SPINE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C-PS is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The C-PS is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The C-PS is intended to be used with a supplemental internal fixation system. The L-PS is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The L-PS System 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 device is to be used in patients who have had six months of non-operative treatment. The L-PS is intended to be used with a supplemental internal fixation system.
    Device Description
    The C-PS comprises a closed annular ring, a hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces for resisting migration and expulsion. The L-PS comprises a closed annular ring with integral anteroposterior cross-piece, a hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces for resisting migration and expulsion.
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    K Number
    K092070
    Device Name
    INTERPLATE C
    Manufacturer
    RSB SPINE LLC.
    Date Cleared
    2009-10-06

    (90 days)

    Product Code
    KWQ, KWO, ODP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    RSB SPINE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
    Device Description
    The InterPlate™ C consists of plates, bone screws and screw covers in a variety of sizes. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size. The InterPlate™ C components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.
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    K Number
    K081194
    Device Name
    INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
    Manufacturer
    RSB SPINE LLC.
    Date Cleared
    2008-05-29

    (31 days)

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

    RSB SPINE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterPlate™ Interbody Fusion Device (IFD) is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The InterPlate™ C, CGC and PEEK OPTIMA® Cervical Systems are intended for usc at onc level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The InterPlate™ L and LGC Systems are 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 device is to be used in patients who have had six months of non-operative treatment.
    Device Description
    The InterPlate™ IFD System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
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    K Number
    K071922
    Device Name
    INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
    Manufacturer
    RSB SPINE LLC.
    Date Cleared
    2007-09-18

    (68 days)

    Product Code
    OVD, KWQ, OVE
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    RSB SPINE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterPlate™ IFD is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The InterPlate™ C and CGC Systems are intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The InterPlate™ L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, 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 device is to be used in patients who have had six months of non-operative treatment.
    Device Description
    The InterPlate™ System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
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    K Number
    K071372
    Device Name
    MODIFICATION TO: INTERPLATE VBR SYSTEM
    Manufacturer
    RSB SPINE LLC.
    Date Cleared
    2007-06-11

    (26 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    RSB SPINE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterPlate™ GC VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.
    Device Description
    The InterPlate™ GC VBR System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
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    K Number
    K070316
    Device Name
    INTERPLATE VBR SYSTEM
    Manufacturer
    RSB SPINE LLC.
    Date Cleared
    2007-04-19

    (77 days)

    Product Code
    MQP, MOP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    RSB SPINE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.
    Device Description
    The InterPlate™ VBR consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
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    K Number
    K061401
    Device Name
    INTERPLATE VBR SYSTEM
    Manufacturer
    RSB SPINE LLC.
    Date Cleared
    2006-08-18

    (91 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    RSB SPINE LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumber spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The InterPlate™ VBR device is intended to be used with a supplemental internal fixation system.
    Device Description
    The InterPlate™ VBR consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
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