Device Recall SLIFT

  • Modèle / numéro de série
    Lot/Serial Numbers: 7201.007 and 7201.007-1
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
  • Description du dispositif
    BASE, S-LIFT Instrument Case || Product Usage: || System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Société-mère du fabricant (2017)
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Numbers: 012064-001
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide including the states of: MA and TX.
  • Description du dispositif
    S-Lift Implant Guides (also known as S-LIF) || Compressor Part Number: 11-50223 || Product Usage: || Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
  • Manufacturer
  • Modèle / numéro de série
    Lot/Serial Numbers: 47175
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA
  • Description du dispositif
    S-LIFT Inserter Outer Sleeve || Product Usage: || The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
  • Manufacturer
  • Modèle / numéro de série
    Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
  • Description du dispositif
    S-LIFT Extension Shims || Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
  • Manufacturer