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510(k) Data Aggregation
K Number
K093669Device Name
SEC IBF CAGE
Manufacturer
INNVOTEC SURGICAL, INC.
Date Cleared
2010-03-18
(111 days)
Product Code
MAX, MOP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
INNVOTEC SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intervertebral Body Fusion Device: The Innvotec Surgical SEC IBF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC IBF Cage is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, the Innvotec Surgical SEC IBF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC IBF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC IBF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC IBF Cage may be used with bone graft.
Device Description
The SEC IBF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The SEC IBF Cage is manufactured from Ti6Al4V and stainless steel.
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K Number
K091743Device Name
SEC VBR
Manufacturer
INNVOTEC SURGICAL, INC.
Date Cleared
2009-11-02
(139 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
INNVOTEC SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Innvotec Surgical SEC VBR is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC VBR is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.
Device Description
The SEC VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial corpectomy. The SEC VBR is manufactured from Ti6Al4V and stainless steel. The SEC VBR is for single level anterior spinal use from T1-L5.
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