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510(k) Data Aggregation
K Number
K122850Device Name
TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
Manufacturer
MEDITECH ADVISORS, LLC
Date Cleared
2013-03-28
(191 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
MEDITECH ADVISORS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion,
Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks.
Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.
Device Description
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K Number
K090707Device Name
TALOS INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer
MEDITECH ADVISORS, LLC
Date Cleared
2009-07-15
(120 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
MEDITECH ADVISORS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Talos™ IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos™ IBF devices are intended to be used with autologous bone graft to facilitate fusion. The Talos™ IBF device is to be used in patients who have had six months of non-operative treatment.
Talos™ IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The Talos™-P device is implanted in pairs, while the Talos™-A, Talos™-L and Talos™-T devices may be implanted singly or in pairs in the lumbosacral spine. The Talos™-A, Talos™-L, Talos™-P, and Talos™-T are intended to be used with supplemental fixation.
Device Description
The Talos™ IBF Device is made of PEEK-OPTIMA®. Talos™ IBF Device is available in four The configurations: Talos™-P, Talos™-T, Talos™-L, and Talos™-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos™-P and Talos™-L are rectangular devices and the Talos™-T and Talos™-A have curved lateral walls and rounded edges. The implants are available in a range of sizes, as well as flat and lordotic angled implants, to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allow the Talos™ IBF radiological confirmation for proper positioning.
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