Devices

Device Recall CeresC Standalone Cervical Interbody, absent the tantalum market pin

  • Modèle / numéro de série
    Part Number 08-170-1010 - Lot Number 134926; Part Number 08-170-1011 - Lot Number 134927; Part Number 08-170-1006 - Lot Number 134929; Part Number 08-170-1008 - Lot Number 134931
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to GA only.
  • Description du dispositif
    Ceres-C Standalone Cervical Interbody || The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
  • Manufacturer
    Amendia, Inc
  • 1 Event

Fabricant

Amendia, Inc
  • Adresse du fabricant
    Amendia, Inc, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • Société-mère du fabricant (2017)
    Spinal Elements
  • Source
    USFDA