Medtronic Sofamor Danek CD Horizon Spinal System Sextant™

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Tilgjengelig fra:

MEDTRONIC INTERNATIONAL, LTD.

Klasse:

Class C medical device

Produsert av:

Medtronic Sofamor Danek USA, Inc.

Terapeutisk område:

Orthopaedics

Indikasjoner:

When used in a percutaneous posterior approach with SEXTANT instrumentation, the components are intended for the following indications: As a pedicle screw fixation system it is indicated for skeletally mature patients: having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); or, who are having the device removed after the development of a solid fusion mass. When used as a posterior spine thoracic/lumbar system, the components are intended for: degenerative disc disease; spinal stenosis; spondylolisthesis; spinal deformities; fracture; pseudarthrosis; tumor resection; and/or failed previous fusion.

Produkt oppsummering:

Device System Info:[System or Procedure Pack], Consists of cannulated M8 Multi-Axial Screw, pre-bent rod and rod insertion system instrumentation; Models: Sextant Guidewire, Blunt - 8670001, Sextant Guidewire, Sharp - 8670002, Sextant Quick Connect Trocar - 8670000, Sextant Quick Connect Pedicle Probe - 8670003, Sextant Guidewire Centering Sleeve - 8670004, Sextant Trocar/Probe Sleeve - 8670007, Sextant M8 MAS Srcewdiver - 8670020, Sextant Reattachment Driver - 8670021, Sextant Rod Trocar Tip - 8670030, Sextant Combination Plug Driver - 8670040, Sextant 4.5mm Tap - 8670045, Sextant 5.5mm Tap - 8670055, Sextant 6.5mm Tap - 8670065, Sextant Self Drilling Tap - 8670085, Sextant Final Plug Driver Shaft - 8670090, Sextant Compressor Handle - 8670095, Sextant Rod Template - 8670096, Sextant Rod Inserter Assembly - 8675300, Sextant Large Dilator - 8675422, M8 Set Screws, Ti - 8670855, 5.5mm Pre-Bent Rod, L=20mm, Ti - 8671020, 5.5mm Pe-Bent Rod, L=25mm,Ti - 8671025, 5.5mm Pre-Bent Rod, L=30mm, Ti - 8671030, 5.5mm Pre-Bent Rod, L=35mm, Ti - 8671035, 5.5mm Pre-Bent Rod, L=40mm, Ti - 8671040, 5.5mm Pre-Bent Rod, L=45mm, Ti - 8671045, 5.5mm Pe-Bent Rod, L=50mm, Ti - 8671050, 5.5mm Pre-Bent Rod, L=55mm, Ti - 8671055, 5.5mm Pe-Bent Rod, L=60mm,Ti - 8671060, 5.5mm Pre-Bent Rod, L=65mm, Ti - 8671065, 5.5mm Pe-Bent Rod, L=70mm,Ti - 8671070, 5.5mm Pe-Bent Rod, L=75mm, Ti - 8671075, 5.5mm Pe-Bent Rod, L=80mm,Ti - 8671080, 5.5mm Pre-Bent Rod, L=85mm,Ti - 8671085, 5.5mm Pe-Bent Rod, L=90mm, Ti - 8671090, 5.5mm Pe-Bent Rod, L=95mm,Ti - 8671095, 5.5mm Pe-Bent Rod, L=30mm, Ti - 8672030, 5.5mm Pre-Bent Rod, L=35mm, Ti - 8672035, 5.5mm Pe-Bent Rod, L=40mm, Ti - 8672040, 5.5mm Pre-Bent Rod, L=45mm,Ti - 8672045, 5.5mm Pe-Bent Rod, L=50mm,Ti - 8672050, 5.5mm Pre-Bent Rod, L=60mm, Ti - 8672060, 5.5mm Pe-Bent Rod, L=70mm, Ti - 8672070, 5.5mm Pe-Bent Rod, L=80mm,Ti - 8672080, 5.5mm Pe-Bent Rod, L=90mm,Ti - 8672090, Cannulated M8 MAS 5.5x30mm, Ti - 8675530, Cannulated M8 MAS 5.5x35mm, Ti - 8675535, Cannulated M8 MAS 5.5x40mm, Ti - 8675540, Cannulated M8 MAS 5.5x45mm, Ti - 8675545, Cannulated M8 MAS 5.5x50mm, Ti - 8675550, M8 MAS 6.5x30mm, Ti - 8676530, M8 MAS 6.5x35mm, Ti - 8676535, M8 MAS 6.5x40mm, Ti - 8676540, M8 MAS 6.5x45mm, Ti - 8676545, M8 MAS 6.5x50mm, Ti - 8676550, M8 MAS 6.5x55mm, Ti - 8676555, M8 MAS 7.5x30mm, Ti - 8677530, M8 MAS 7.5x35mm, Ti - 8677535, M8 MAS 7.5x40mm, Ti - 8677540, M8 MAS 7.5x45mm, Ti - 8677545, M8 MAS 7.5x50mm, Ti - 8677550, M8 MAS 7.5x55mm, Ti - 8677555, CD Horizon Spinal System Sextant Pre-Bent ROD - 8672025, CD Horizon Spinal System Sextant Pre-Bent ROD - 8672105, CD Horizon Spinal System Sextant Pre-Bent ROD - 8672115, CD Horizon Spinal System Sextant Pre-Bent ROD - 8672120, CD Horizon Spinal System Sextant Pre-Bent ROD - 8672125, CD Horizon Spinal System Sextant Pre-Bent ROD - 8672130

Autorisasjon dato:

2005-05-31