Devices

Device Recall PERPOS PLS SYSTEM

  • Modèle / numéro de série
    LOT #'s: 040309-A, 041409-A
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of to NC, NY, TN & VA
  • Description du dispositif
    PERPOS PLS SYSTEM, CATALOG NO. 9045-01 || A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.
  • Manufacturer
    Interventional Spine Inc
  • 1 Event

Fabricant

Interventional Spine Inc
  • Adresse du fabricant
    Interventional Spine Inc, 13700 Alton Pkwy Ste 160, Irvine CA 92618-1618
  • Société-mère du fabricant (2017)
    Interventional Spine Inc.
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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Device Recall PERPOS PLS System Single Use
  • Modèle / numéro de série
    CATALOG NO. 9045-01, LOT NUMBERS; 010410C, 010508A, 012308A, 021610C, 030309A, 030708A , 031609B, 040209B, 041309B, 050809B, 051309B, 060809B, 061709B, 062009A, 070108A, 070108B, 071009C, 072408A, 102107A, 110909B, 111207A, 120308B, 120807A   CATALOG NO. 9045-02, LOT NUMBERS; 010410D, 010608A, 011910B, 012408A, 020209B, 020309A, 020510C, 021610D, 030409A, 030808A, 031709A, 032310D, 040110A, 040309A, 041409A, 050709B, 050809C, 051209D, 060209A, 060809C, 061709C, 062009B, 070208A, 070208B, 071009D, 072508A, 090408A, 090508A, 090909E, 092209B, 092909A, 092909B, 102207A, 110909C, 111307A, 112208A, 120408C, 120907A
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Word wide Distribution: (USA) Nationwide including the states of CO, CT, FL, KY, LA, MA, NC, NY, OK, OR, TN, TX, VA, and WI; and the countries of Italy, Spain, Turkey, and the U.K.
  • Description du dispositif
    PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. || Interventional Spine, Inc. || A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints.
  • Manufacturer
    Interventional Spine Inc
Device Recall PERPOS PLS SYSTEM
  • Modèle / numéro de série
    LOT #'s: 040209-B, 041309-B
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of to NC, NY, TN & VA
  • Description du dispositif
    PERPOS PLS SYSTEM, CATALOG NO. 9045-02 || A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.
  • Manufacturer
    Interventional Spine Inc