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510(k) Data Aggregation
K Number
K220297Device Name
True Tulip, True M.I.S.
Manufacturer
Innovative Surgical Designs, Inc.
Date Cleared
2022-09-16
(226 days)
Product Code
NKB, KWP
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Innovative Surgical Designs, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
True Tulip is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediation in pediatic patients, the True Tulip is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idopathic scoliosis (AIS), neuromuscular scoliosis, and congental scoliosis. Additionally, the True Tulip is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True Tulip is intended to be used with autograft and/or allograft.
Device Description
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K Number
K212627Device Name
True Tulip, True M.I.S.
Manufacturer
Innovative Surgical Designs, Inc.
Date Cleared
2022-02-18
(183 days)
Product Code
NKB, KWP
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Innovative Surgical Designs, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
True Tulip and True M.I.S. are intended for posterical (TI-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, sooliosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediatic patients, True Tulip and True M.I.S. are indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. Additionally, True Tulip and True M.I.S. are intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pedicle screw fixation is limited to a posterior approach. True Tulip and True M.I.S. are intended to be used with autograft and/or allograft.
Device Description
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K Number
K210816Device Name
True Tulip, True M.I.S.
Manufacturer
Innovative Surgical Designs, Inc.
Date Cleared
2021-05-18
(61 days)
Product Code
NKB, KWP
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Innovative Surgical Designs, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
True Tulip is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediation in pediatic patients, the True Tulip is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the True Tulip is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True Tulip is intended to be used with autograft and/or allograft.
True M.I.S. is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic. lumbar. and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediatic patients, the True M.I.S. is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idionathic scoliosis (AIS), neuromuscular scoliosis. Additionally, the True M.I.S. is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma. pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True M.I.S. is intended to be used with autograft and/or allograft.
Device Description
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K Number
K201780Device Name
True Tulip System, True M.I.S. System
Manufacturer
Innovative Surgical Designs, Inc.
Date Cleared
2020-07-22
(22 days)
Product Code
NKB, KWP
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Innovative Surgical Designs, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
True Tulip and True M.I.S. are intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, True Tulip and True M.I.S. are indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, True Tulip and True M.I.S. are intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pedicle screw fixation is limited to a posterior approach. True Tulip and True M.I.S. are intended to be used with autograft and/or allograft.
Device Description
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K Number
K181584Device Name
Redi-Spine
Manufacturer
Innovative Surgical Designs, Inc.
Date Cleared
2018-08-10
(56 days)
Product Code
NKB, KWP
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Innovative Surgical Designs, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Redi-Spine is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, syphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
When used for posterior non-cervical pediatic patients, the Redi-Spine is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. Additionally, the Redi-Spine is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach. The Redi-Spine is intended to be used with autograft and/or allograft.
Device Description
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K Number
K171559Device Name
True Spinal Fixation System
Manufacturer
Innovative Surgical Designs, Inc.
Date Cleared
2017-07-24
(55 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Innovative Surgical Designs, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Device Description
Not Found
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K Number
K170710Device Name
True Spinal Fixation System
Manufacturer
Innovative Surgical Designs, Inc.
Date Cleared
2017-07-14
(128 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Innovative Surgical Designs, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Device Description
Not Found
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K Number
K133690Device Name
TRUE SPINAL FUSSION SYSTEM
Manufacturer
INNOVATIVE SURGICAL DESIGNS
Date Cleared
2014-05-07
(156 days)
Product Code
MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE SURGICAL DESIGNS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Device Description
The True™ Spinal Fixation System consists of pairs of longitudinal members (rods), anchors (polyaxial pedicle screws) and interconnections (rod-rod connectors). The changes include a rod to rod connector for ease of delivery, thermoformed instruments to replace the stainless steel instruments, a lower final torque value of 7.5Nm previously 8.5 Nm
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K Number
K130958Device Name
TRUE SPINAL FIXATION SYSTEM
Manufacturer
INNOVATIVE SURGICAL DESIGNS
Date Cleared
2013-10-17
(195 days)
Product Code
MNI, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE SURGICAL DESIGNS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Device Description
The True™ Spinal Fixation System consists of pairs of longitudinal members (rods), anchors (polyaxial pedicle screws) and interconnections (rod-rod connectors). These are available in a variety of sizes to accommodate differing patient anatomy. Dual Rod use Only. The True™ Spinal Fixation System is intended to be used only as a dual rod system and must be used with two rods per connector in all cases. Do not use one rod per connector.
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