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510(k) Data Aggregation
K Number
K150913Device Name
INCITE ANCHORED CERVICAL INTERBODY DEVICE
Manufacturer
Date Cleared
2015-04-30
(24 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
INCITE INNOVATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
Device Description
The Incite Anchored Cervical Interbody (ACI) Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Device is manufactured from PEEK and Ti 6A1 4V titanium alloy with tantalum radiopaque markers.
Purpose of this 510(k) submission: The purpose of this submission is to add the updated ACI II Inserter to the ACI System. The ACI II Inserter is used with the Incite Innovation Anchored Cervical Interbody Device. The inserter places the implant in the surgical site, deploys the anchor and detaches from the implant. The patient contacting material of the inserter is stainless steel (SS 17-4). The ACI II Inserter has been modified to be smaller, lighter in weight and easier to use.
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K Number
K130306Device Name
INCITE ANCHORED CERVICAL INTERBODY DEVICE
Manufacturer
Date Cleared
2013-04-11
(63 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
INCITE INNOVATION LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
Device Description
The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers
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K Number
K122008Device Name
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
Manufacturer
Date Cleared
2012-11-16
(130 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
INCITE INNOVATION LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
Device Description
The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers.
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K Number
K093808Device Name
INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE
Manufacturer
Date Cleared
2010-03-24
(103 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
INCITE INNOVATION LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Incite Interbody Fusion Device is intended for anterior intervertebral body fusion of the lumbar spine at one or two contiguous levels from L2-S1. The device is indicated for patients with lumbar degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients treated should be skeletally mature and have received a minimum of six months of non-operative treatment. The Incite Interbody Fusion Device is designed for use with additional supplemental fixation and with autograft to facilitate fusion.
Device Description
The Incite Interbody Fusion Device (IBFD) is an ALIF implant that incorporates the benefit of a radiolucent interbody spacer equipped with internal fixation anteriorly through the use of an integrated anchoring mechanism. The implant is made from materials with a long history of use in this type of application which include PEEK, titanium alloy, and tantalum. The implant has two chambers to accommodate autograft.
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