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510(k) Data Aggregation
K Number
K092540Device 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
888.3080Why 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
K092070Device Name
INTERPLATE C
Manufacturer
RSB SPINE LLC.
Date Cleared
2009-10-06
(90 days)
Product Code
KWQ, KWO, ODP
Regulation Number
888.3060Why 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
K081194Device 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
888.3080Why 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
K071922Device 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
888.3080Why 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
K071372Device Name
MODIFICATION TO: INTERPLATE VBR SYSTEM
Manufacturer
RSB SPINE LLC.
Date Cleared
2007-06-11
(26 days)
Product Code
MQP
Regulation Number
888.3060Why 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
K070316Device Name
INTERPLATE VBR SYSTEM
Manufacturer
RSB SPINE LLC.
Date Cleared
2007-04-19
(77 days)
Product Code
MQP, MOP
Regulation Number
888.3060Why 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
K061401Device Name
INTERPLATE VBR SYSTEM
Manufacturer
RSB SPINE LLC.
Date Cleared
2006-08-18
(91 days)
Product Code
MQP
Regulation Number
888.3060Why 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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