Medtronic Sofamor Danek LT-CAGE™ PEEK Lumbar Tapered Fusion Device

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

MAH:

MEDTRONIC INTERNATIONAL, LTD.

class:

Class C medical device

manufactured_by:

Medtronic Sofamor Danek USA, Inc.

therapeutic_area:

Orthopaedics

therapeutic_indication:

It is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. LT-Cage™ PEEK implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the LT-Cage™ PEEK Lumbar Tapered Fusion Device should have at least six months of non-operative treatment prior treatment with the LT-Cage™ PEEK device

leaflet_short:

Device System Info:[Sterile Medical Device], Sterilization by Radiation.; Models: Instruemtn Remover, Large - 890-501, Quick Disconnect T-handle - 890-502, Implant Driver Wrench - 8950003, Adjustable Depth Stop - 902-112, Pituitary Rongeur, 4mmx12mm - 9115780, Distractor Tip, 6mm - 9115806, Distractor Tip, 8mm - 9115808, Distractor Tip, 10mm - 9115810, Distractor Tip, 12mm - 9115812, Distractor Tip, 14mm - 9115814, Distractor Tip, 16mm - 9115816, Housing Assembly - 9115826, Housing Insert - 9115874, Driver Cap - 9115877, 6mm Trephine - 9116883, Seal Kit - 9119870, Tapered Implant Hollow Reamer, 14mm - 9110252, Implant Holder, 14mm x20mm - 9110261, Sizing Adapter, 14mm Tapered - 9110270, Trephine Guide, 14mm Tapered - 9110280, Outer Sleeve, 16mm Tapered - 9110312, Tapered Implant Driver Sleeve, 16mm - 9110365, Implant Holder, 16x26mm - 9110368, Implant Adjuster, 16mm Tapered - 9110376, Outer Sleeve, 18mm Tapered - 9110410, Tapered Implant Driver Sleeve, 18mm - 9110460, Sizing Adapter, 18mm Tapered - 9110470, Trephine Guide, 18mm Tapered - 9110480

authorization_date:

2005-09-14