Stryker Spine Torque Wrench

  • 모델명 / 제조번호(시리얼번호)
    Medical Device Listing Number E207315  1) XIA Torque Wrench Catalog # 03807028 Lot # 127510, 092793, 097089, 11E038, 11E039, 11E040, 11E041, 123746, 127179, &12D012  2) XIA 3 Torque Wrench Catalog # 48237028 Lot # 11E042, 11E044, 11E047, 098525, 118823, 11E043, 11E045, 11E046, 11E048, 127647, R127647, 12A646, & R12A646  3) XIA Elegance Short Torque Wrench Catalog # 482397028 Lot # 11A957, 11E035, 11E036, R11E036, & 121098  4) Mantis Redux Torque Wrench Reference Number 48287028 Lot # 098401, 125708, 125709, 127051 & 12A641
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.
  • 제품 설명
    Stryker || 1) XIA Torque Wrench || 2) XIA 3 Torque Wrench || 3) XIA Elegance Short Torque Wrench || Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 || http://www.stryker.com || Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 || XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • 제조사 모회사 (2017)
  • Source
    USFDA