P000058 Medtronic Sofamor Danek InFUSE Bone Graft .


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P000058 Medtronic Sofamor Danek Mix ? Bone Union/LT-Confine Lumbar Decreased Combination Gadget. Therapeutic Gadgets Branch Division of General, Helpful and Neurological Gadgets Office of Gadget Assessment Place for Gadgets and Radiological Wellbeing. Aric Kaiser, MS - PMA lead commentator
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Slide 1

P000058 Medtronic Sofamor Danek InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device Restorative Devices Branch Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Aric Kaiser, MS - PMA lead analyst Peter Hudson, PhD - lead preclinical commentator Barbara Buch, MD - clinical analyst Telba Irony, PhD - measurable analyst Review group Primary audit group

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Angel Torres-Cabassa, CDRH Martin Yahiro, CDRH Sergio Gadaleta, CDRH Erin Keith, CDRH Kevin Lee, CDRH Tracey Bourke, CDRH Nirmal Mishra, CDRH Carol Arras, CDRH Mary Ann Wollerton, CDRH Pam Reynolds, CDRH Josie Yang, CDER Mercedes Serabian, CBER Barbara Wilcox, CBER John Hill, CBER Gary Kikuchi, CBER Carol Rehkopf, CBER Review group Additional survey skill

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Device depiction InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device 3 part spinal combination gadget spinal embed development figure bearer

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Device portrayal InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device segment 1 LT-Cage Lumbar Tapered Fusion Device Ti composite decreased spinal combination confine PMA endorsed for use with autograft to treat ddd

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Device depiction InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device segments 2 and 3 InFUSE  Bone Graft comprising of: rhBMP-2 (recombinant human bone morphogenetic protein 2) ACS (absorbable collagen wipe)

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Data audit Preclinical portrayal of combination enclosure segment unaltered from affirmed gadget no extra audit essential portrayal of BMP and transporter concentrate on issues identified with FDA questions

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Data audit Clinical and factual discourse and investigation of clinical and radiographic results concentrate on issues identified with FDA questions

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Panel questions Reproduction and teratogenicity Tumorogenicity Radiographic viability Instructions for utilize Postmarket thinks about

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