Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
NUVASIVE SOUTHEAST ASIA PTE. LTD.
Class C medical device
Nuvasive Inc
Orthopaedics
It is indicated for intervertebral body fusion of the spine in skeletally mature patients and is designed for use with autogenous bone graft to facilitate fusion. The CoRoent S platforms are intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from levels C2-C3 to C7- T1. It is to be used in patients who have had at least six weeks of non-operative treatment and is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion. It may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems.
Device System Info:[System or Procedure Pack], It consisted of the implants and instrument.; Models: 5 X 11 X 14mm CoRoent Small I - 6805115, 6 X 11 X 14mm CoRoent Small I - 6806115, 7 X 11 X 14mm CoRoent Small I - 6807115, 8 X 11 X 14mm CoRoent Small I - 6808115, 9 X 11 X 14mm CoRoent Small I - 6809115, 10 X 11 X 14mm CoRoent Small I - 6810115, 11 X 11 X 14mm CoRoent Small I - 6811115, 12 X 11 X 14mm CoRoent Small I - 6812115, 5X11X14mm CoRoent CR-S Assy - 6805114, 6X11X14mm CoRoent CR-S Assy - 6806114, 7X11X14mm CoRoent CR-S Assy - 6807114, 8X11X14mm CoRoent CR-S Assy - 6808114, 9X11X14mm CoRoent CR-S Assy - 6809114, 10X11X14mm CoRoent CR-S Assy - 6810114, 11X11X14mm CoRoent CR-S Assy - 6811114, 12X11X14mm CoRoent CR-S Assy - 6812114, CoRoent SLP - 5 X 13 X 15mm - 6805815, CoRoent SLP - 6 X 13 X 15mm - 6806815, CoRoent SLP - 7 X 13 X 15mm - 6807815, CoRoent SLP - 8 X 13 X 15mm - 6808815, CoRoent SLP - 9 X 13 X 15mm - 6809815, CoRoent SLP - 10 X 13 X 15mm - 6810815, CoRoent SLP - 11 X 13 X 15mm - 6811815, CoRoent SLP - 12 X 13 X 15mm - 6812815, 5x11x14mm CoRoent CR-S 5° Lordotic Assy - 6805714, 6x11x14mm CoRoent CR-S 5° Lordotic Assy - 6806714, 7x11x14mm CoRoent CR-S 5° Lordotic Assy - 6807714, 8x11x14mm CoRoent CR-S 5° Lordotic Assy - 6808714, 9x11x14mm CoRoent CR-S 5° Lordotic Assy - 6809714, 10x11x14mm CoRoent CR-S 5° Lordotic Assy - 6810714, 11x11x14mm CoRoent CR-S 5° Lordotic Assy - 6811714, 12x11x14mm CoRoent CR-S 5° Lordotic Assy - 6812714, Open Contour Spacer 4S - 6840104, Open Contour Spacer 5S - 6840105, Open Contour Spacer 6S - 6840106, Open Contour Spacer 7S - 6840107, Open Contour Spacer 8S - 6840108, Open Contour Spacer 9S - 6840109, Open Contour Spacer 10S - 6840110, Open Contour Spacer 4M - 6840204, Open Contour Spacer 5M - 6840205, Open Contour Spacer 6M - 6840206, Open Contour Spacer 7M - 6840207, Open Contour Spacer 8M - 6840208, Open Contour Spacer 9M - 6840209, Open Contour Spacer 10M - 6840210, Strut Contour Spacer 4L - 6840604, Strut Contour Spacer 5L - 6840605, Strut Contour Spacer 6L - 6840606, Strut Contour Spacer 7L - 6840607, Strut Contour Spacer 8L - 6840608, Strut Contour Spacer 9L - 6840609, Strut Contour Spacer 10L - 6840610, COROENT SMALL CONTOURED, SIZE S4 - 6850104, COROENT SMALL CONTOURED, SIZE S5 - 6850105, COROENT SMALL CONTOURED, SIZE S6 - 6850106, COROENT SMALL CONTOURED, SIZE S7 - 6850107, COROENT SMALL CONTOURED, SIZE S8 - 6850108, COROENT SMALL CONTOURED, SIZE M4 - 6850204, COROENT SMALL CONTOURED, SIZE M5 - 6850205, COROENT SMALL CONTOURED, SIZE M6 - 6850206, COROENT SMALL CONTOURED, SIZE M7 - 6850207, COROENT SMALL CONTOURED, SIZE M8 - 6850208, COROENT SMALL CONTOURED L4 - 6850604, COROENT SMALL CONTOURED L5 - 6850605, COROENT SMALL CONTOURED L6 - 6850606, COROENT SMALL CONTOURED L7 - 6850607, COROENT SMALL CONTOURED L8 - 6850608, CoRoent® Contour, 9mm Small Open - 6852109, CoRoent® Contour, 10mm Small Open - 6852110, CoRoent® Contour, 9mm Medium Open - 6852209, CoRoent® Contour, 10mm Medium Open - 6852210, 9L 9mm Contoured LG (spec. Ord) - 6852609, 10L 10mm Contoured LG (spec. Ord) - 6852610, CoRoent® Contour, 4mm Extra Small 13x11 - 6850004, CoRoent® Contour, 5mm Extra Small 13x11 - 6850005, CoRoent® Contour, 6mm Extra Small 13x11 - 6850006, CoRoent® Contour, 7mm Extra Small 13x11 - 6850007, CoRoent® Contour, 8mm Extra Small 13x11 - 6850008, CoRoent® Contour, 9mm Extra Small 13x11 - 6850009, CoRoent® Contour, 10mm Extra Small 13x11 - 6850010, CoRoent® Small, 13x11x14mm - 6823114, CoRoent® Small, 14x11x14mm - 6824114, CoRoent® Small, 15x11x14mm - 6825114, CoRoent® Small, 16x11x14mm - 6826114, CoRoent® Small Lordotic Plus, 13x13x15mm - 6813815, CoRoent® Small Lordotic Plus, 14x13x15mm - 6814815, CoRoent® Small Lordotic Plus, 15x13x15mm - 6815815, CoRoent® Small Lordotic Plus, 16x13x15mm - 6816815, 13 x 11 x 14mm CoRoent CR-S 5° Lordotic - 6813714, 14 x 11 x 14mm CoRoent CR-S 5° Lordotic - 6814714, 15 x 11 x 14mm CoRoent CR-S 5° Lordotic - 6815714, 16 x 11 x 14mm CoRoent CR-S 5° Lordotic - 6816714, CoRoent® Small Interlock, 5x17x14mm 7° - 6780225, CoRoent® Small Interlock, 6x17x14mm 7° - 6780226, CoRoent® Small Interlock, 7x17x14mm 7° - 6780227, CoRoent® Small Interlock, 8x17x14mm 7° - 6780228, CoRoent® Small Interlock, 9x17x14mm 7° - 6780229, CoRoent® SI, 12x3.5mm Self-Tap FR FA - 6780712, CoRoent® SI, 14x3.5mm Self-Tap FR FA - 6780714, CoRoent® SI, 16x3.5mm Self-Tap FR FA - 6780716, CoRoent® SI, 14x4.0mm Self-Tap FR FA - 6780814, CoRoent® SI, 16x4.0mm Self-Tap FR FA - 6780816, CoRoent® SI Screw, 12x3.5mm Self-Tapping - 6790712, CoRoent® SI Screw, 13x3.5mm Self-Tapping - 6790713, CoRoent® SI Screw, 14x3.5mm Self-Tapping - 6790714, CoRoent® SI Screw, 15x3.5mm Self-Tapping - 6790715, CoRoent® SI Screw, 16x3.5mm Self-Tapping - 6790716, CoRoent® SI Screw, 12x4.0mm Rescue - 6790812, CoRoent® SI Screw, 13x4.0mm Rescue - 6790813, CoRoent® SI Screw, 14x4.0mm Rescue - 6790814, CoRoent® SI Screw, 15x4.0mm Rescue - 6790815, CoRoent® SI Screw, 16x4.0mm Rescue - 6790816, 6x18x12-5°COROENT SL - 6806817, 6x18x12-5°COROENT SL - 6806818, 6x15x13-7°COROENT SLP - 6806819, 6x15x13-7°COROENT SLP - 6806821, 7x18x12-5°COROENT SL - 6807817, 7x18x12-5°COROENT SL - 6807818, 7x15x13-7°COROENT SLP - 6807819, 7x15x13-7°COROENT SLP - 6807821, 8x18x12-5°COROENT SL - 6808817, 8x18x12-5°COROENT SL - 6808818, 8x15x13-7°COROENT SLP - 6808819, 8x15x13-7°COROENT SLP - 6808821, 9x18x12-5°COROENT SL - 6809817, 9x18x12-5°COROENT SL - 6809818, 9x15x13-7°COROENT SLP - 6809819, 9x15x13-7°COROENT SLP - 6809821, 10x18x12-5°COROENT SL - 6810817, 10x18x12-5°COROENT SL - 6810818, 10x15x13-7°COROENT SLP - 6810819, 10x15x13-7°COROENT SLP - 6810821, 11x18x12-5°COROENT SL - 6811817, 11x18x12-5°COROENT SL - 6811818, 11x15x13-7°COROENT SLP - 6811819, 11x15x13-7°COROENT SLP - 6811821, 12x18x12-5°COROENT SL - 6812817, 12x18x12-5°COROENT SL - 6812818, 12x15x13-7°COROENT SLP - 6812819, 12x15x13-7°COROENT SLP - 6812821, 13x18x12-5°COROENT SL - 6813817, 13x18x12-5°COROENT SL - 6813818, 13x15x13-7°COROENT SLP - 6813819, 13x15x13-7°COROENT SLP - 6813821, 14x18x12-5°COROENT SL - 6814817, 14x18x12-5°COROENT SL - 6814818, 14x15x13-7°COROENT SLP - 6814819, 14x15x13-7°COROENT SLP - 6814821, 15x18x12-5°COROENT SL - 6815817, 15x18x12-5°COROENT SL - 6815818, 15x15x13-7°COROENT SLP - 6815819, 15x15x13-7°COROENT SLP - 6815821, 16x18x12-5°COROENT SL - 6816817, 16x18x12-5°COROENT SL - 6816818, 16x15x13-7°COROENT SLP - 6816819, 16x15x13-7°COROENT SLP - 6816821, CoRoent® Small, 4x17x12mm 7° Ta Markers - 6717104, CoRoent® Small, 5x17x12mm 7° Ta Markers - 6717105, CoRoent® Small, 6x17x12mm 7° Ta Markers - 6717106, CoRoent® Small, 7x17x12mm 7° Ta Markers - 6717107, CoRoent® Small, 8x17x12mm 7° Ta Markers - 6717108, CoRoent® Small, 9x17x12mm 7° Ta Markers - 6717109, CoRoent® Small, 10x17x12mm 7° Ta Markers - 6717110, CoRoent® Small, 11x17x12mm 7° Ta Markers - 6717111, CoRoent® Small, 3x17x12mm 10° Ta Markers - 6717203, CoRoent® Small, 4x17x12mm 10° Ta Markers - 6717204, CoRoent® Small, 5x17x12mm 10° Ta Markers - 6717205, CoRoent® Small, 6x17x12mm 10° Ta Markers - 6717206, CoRoent® Small, 7x17x12mm 10° Ta Markers - 6717207, CoRoent® Small, 8x17x12mm 10° Ta Markers - 6717208, CoRoent® Small, 9x17x12mm 10° Ta Markers - 6717209, CoRoent® Small, 10x17x12mm 10° Ta Marker - 6717210, CoRoent® Small, 3x17x12mm 15° Ta Markers - 6717303, CoRoent® Small, 4x17x12mm 15° Ta Markers - 6717304, CoRoent® Small, 5x17x12mm 15° Ta Markers - 6717305, CoRoent® Small, 6x17x12mm 15° Ta Markers - 6717306, CoRoent® Small, 7x17x12mm 15° Ta Markers - 6717307, CoRoent® Small, 8x17x12mm 15° Ta Markers - 6717308, CoRoent® Small, 9x17x12mm 15° Ta Markers - 6717309, CoRoent®Small, 10x17x12mm 15° Ta Markers - 6717310, CoRoent® Small, 3x17x12mm 20° Ta Markers - 6717403, CoRoent® Small, 4x17x12mm 20° Ta Markers - 6717404, CoRoent® Small, 5x17x12mm 20° Ta Markers - 6717405, CoRoent® Small, 6x17x12mm 20° Ta Markers - 6717406, CoRoent® Small, 7x17x12mm 20° Ta Markers - 6717407, CoRoent® Small, 8x17x12mm 20° Ta Markers - 6717408, CoRoent® Small, 9x17x12mm 20° Ta Markers - 6717409, CoRoent® Small, 10x17x12mm 20° Ta Marker - 6717410, CoRoent® Small, 3x17x12mm 25° Ta Markers - 6717503, CoRoent® Small, 4x17x12mm 2
2010-12-01