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

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to GA only.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Amendia, Inc, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • 제조사 모회사 (2017)
  • Source
    USFDA