TPlate

  • Modèle / numéro de série
    (UDI)/Lot: a) (18056099647762) B1098805; b) (18056099647779) B1102020
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
  • Description du dispositif
    T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Société-mère du fabricant (2017)
  • Source
    USFDA

7 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
  • Description du dispositif
    md
  • Manufacturer
  • Modèle / numéro de série
    a) 120 MM, Product Code 99-56-22000, Lot No. V1374370 (Lot No. laser marked on products V1369866, V1369865, V1369864), Exp. Date 06/08/2019, UDI 18054242512585;   b) 140 MM, Product Code 99-56-22020, Lot No. V1374298 (Lot No. laser marked on products V1369870, V1369868, V1369869, V1369872, V1369871), Exp. Date 06/07/2019, UDI 18054242512592;   c) 160 MM, Product Code 99-56-22040, Lot No. V1374255 (Lot No. laser marked on products V1370134, V1370136, V1370128, V1370133, V1370132, V1370131), Exp. Date 06/07/2019, Lot No. V1374374 (Lot No. laser marked on products V1370130), Exp. Date 06/08/2019, Lot No. R1065030 (Lot No. laser marked on products V1370134, V1370136, V1370128, V1370133, V1370132, V1370131), Exp. Date 12/16/2021, UDI 18054242512608;   d) 180 MM, Product Code 99-56-22060, Lot No. V1374259 (Lot No. laser marked on products V1370581, V1369468, V1369469, V1369467, V1369466, V1369465, V1369471, V1369470, V1370597), Exp. Date 06/07/2019, UDI 18054242512615;   e) 200 MM, Product Code 99-56-22080, Lot No. V1374361 (Lot No. laser marked on products V1369462, V1371128, V1371074, V1369463, V1370469), Exp. Date 06/08/2019, UDI 18054242512622;   f) 220 MM, Product Code 99-56-22100, Lot No. V1374373 (Lot No. laser marked on products V1369460, V1371250, V1371075), Exp. Date 06/08/2019, UDI 18054242512639
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution within Texas., and to the countries of : Australia, Belgium, Chile, Denmark, France, Germany, Israel, Italy, Japan, South Africa, Spain, Sweden, Switzerland and United Kingdom.
  • Description du dispositif
    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. || The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.
  • Manufacturer
  • Modèle / numéro de série
  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Non-active implants - bone surgery
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Orthofix: DOUBLE ROW FOOTPLATES, TL-HEX STERILE, ALL SIZES
  • Manufacturer
  • Modèle / numéro de série
    all sizes; 99-56-22000, 99-56-22020, 99-56-22040, 99-56-22060, 99-56-22080, 99-56-22100 | V1374370, V1374298, V1374255, V1374374, V1374259, V1374361, V1374373, R1065030
  • Description du dispositif
    MD: External orthopaedic fixation system, single-use, sterile
  • Manufacturer
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