Materialise USA LLC

7 dispositifs dans la base de données

  • Modèle / numéro de série
    00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to MN only
  • Description du dispositif
    Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
  • Modèle / numéro de série
    Lot 094929
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution: MO only.
  • Description du dispositif
    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE || SIGNATURE || M PKA GDE/MDL SET SML-MP || DD.....R-FEB55RKA-T JA-A01 05551 || PKA POST CUT SML-PKA MICROPLASTY || CUSTOM-MADE DEVICE || non-sterile || The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
  • Modèle / numéro de série
    Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
  • Distribution
    Distributed in Canada.
  • Description du dispositif
    ProPlan CMF Guide(s) Model(s) || REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. || Used as surgical tools to transfer a pre-operative plan to surgery. || .
  • Modèle / numéro de série
    Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01
  • Distribution
    Distributed in Canada.
  • Description du dispositif
    ProPlan CMF Guide(s) Model(s) || REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. || Used as surgical tools to transfer a pre-operative plan to surgery.
  • Modèle / numéro de série
    Lot 56529886, REF 005970-000-03 Exp 2012-09-08
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including the states of Ohio and Minnesota.
  • Description du dispositif
    PATIENT SPECIFIC INSTRUMENTS || N-K FLEX PIN GUIDES (FEMUR AND TIBIA) || NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE || Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI || Distributed by Zimmer, Warsaw IN. || Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
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