ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

  • Modelo / Serial
    Model# 800804 Lot numbers 160010 and 170003
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationally
  • Descripción del producto
    AccuLIF TL Insertion Handle || The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral space, and then through activation of the rotational pivot between the Handle and implant for final placement of the crescent-shaped cage across the anterior portion of the disc space. The AccuLIF TL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Howmedica Osteonics Corp., 2 Pearl Ct, Allendale NJ 07401-1611
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Part #: PI-0507, Lot #s:1308811A, 1457704A; Part #: PI-0508, Lot #s: 1308812A, 1457705A; Part #: PI-0509, Lot #s: 1038813A, 1457706A; Part #: PI-0510, Lot #s: 1308814A, 1457707A; Part #: PI-0511, Lot #s: 1308815A, 1457708A; Part #: PI-0512, Lot #s: 1308816A, 1457709A; Part #: PI-0513, Lot #s: 1308817A, 1457710A; Part #: PI-0514, Lot #s: 1308818A, 1457711A; Part #: PI-0507-S, Lot #: 2130005; Part #: PI-0508-S, Lot #: 2130006; Part #: PI-0509-S, Lot #: 2130007; Part #: PI-0510-S, Lot #: 2130008; Part #: PI-0511-S, Lot #: 2130009; Part #: PI-0512-S, Lot #: 2130010; Part #: PI-0513-S, Lot #:2130011; Part #: PI-0514-S, Lot #: 2130012
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    GA, IN, FL, UT, AZ, CA, and NY
  • Descripción del producto
    Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
  • Manufacturer
  • Modelo / Serial
    Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
  • Descripción del producto
    HipLOC CHS Plate/Lag Screw Introducer
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Reusable Products
  • Manufacturer
  • Modelo / Serial
    Lot Number: PM3979
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution only in Texas.
  • Descripción del producto
    Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 || Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System .
  • Manufacturer
  • Modelo / Serial
    Catalog numbers: 32-481000  Lot Numbers: 615860, 765230  Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
  • Descripción del producto
    Compress Face Reamer || Product Usage: || Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
  • Manufacturer