Stryker Spine

89 devices in the database

  • Model / Serial
    Lot #144933, 14D252, and 14D253.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France || Used to facilitate insertion of the Aero-AL cage into the disc space.
  • Model / Serial
    Catalog number 900301, Lot #01131543, 01261508, 10151404, 10271408, 12161403, 12161404, 09021404, 01261509, 10271407, 01261507, 10071415, 05011403, 06241407, 08071402, 10091305, 03041403, 01271412, 07281401, and 11061303. Catalog number 905103, 01131542, 11241408, 12161405, 12161406, 0211501, 01211502, 11241406, 02031403, 06241408, 07161407, 09101402, 09281401, 10251303, 05301402, 11241407, and 12101305.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    AccuLIF PL Tubing Set and AccuLIF TL Tubing Set || AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from a syringe to the AccuLIF implant for in-situ expansion. The Tubing Set attaches to the AccuLIF Insertion handle at two district locations: the "junction block" and the "manifold." The PL and TL Tubing Sets are Class 2 instruments not intended to sustain or support life.
  • Model / Serial
    Lot Code: 093309
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.
  • Product Description
    LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. || Provides access to the thoracic and lumbar spine from a posterior approach via a small incision.
  • Model / Serial
    Code information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows:  48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201  48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197   48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198  48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599  48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in Atlanta, Georgia.
  • Product Description
    The Instructions For Use for the following: || Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW || Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW || Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW || Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW || Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW || 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 Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. || The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.
  • Model / Serial
    Class I device, 510(K) exempt  Catalog Number: 48237028 Lot Number: 093653, 093654, 093655
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
  • Product Description
    Stryker XIA 3 TORQUE WRENCH || REF 48237028 || Manufactured by: || Stryker pine 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 Ct. Allendale || NJ 07401-1677 USA || +1-201-780-8000 || The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.
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    AEMPSVFOI
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  • Source
    BAM
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