Ulnar Shortening Saw Blade

  • Modèle / numéro de série
    Part Number: 80-0499-S Lot Numbers: 214436, 215637, 215638, 215639, 215640, 215641, 219931, and 220909.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA and to the following countries: Spain, Great Britain, South Africa, Puerto Rico, Canada, Turkey, Ireland, Finland, Belgium, Australia, Germany, and Sweden.
  • Description du dispositif
    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". || The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. || The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. || Intended use: Cutting Bones
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Société-mère du fabricant (2017)
  • Source
    USFDA

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