Ebi, Llc

  • 제조사 주소
    Ebi, Llc, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA
  • 4 Events

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 4 건

  • 모델명 / 제조번호(시리얼번호)
    Item Number: 14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM CANN TRANS 14-571860 5.5 TI 10.5X60MM CANN TRANS 14-571865 5.5 TI 10.5X65MM CANN TRANS 14-571870 5.5 TI 10.5X70MM CANN TRANS 14-571875 5.5 TI 10.5X75MM CANN TRANS 14-571880 5.5 TI 10.5X80MM CANN TRANS 14-571885 5.5 TI 10.5X85MM CANN TRANS 14-571890 5.5 TI 10.5X90MM CANN TRANS 14-571895 5.5 TI 10.5X95MM CANN TRANS 14-571899 5.5 TI 10.5X100MM CANN TRANS
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
  • 제품 설명
    Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. || Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 14-501669; Lot Number 006731
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the country The Netherlands.
  • 제품 설명
    Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
  • 모델명 / 제조번호(시리얼번호)
    14-535140 12 mm 6-deg narrow 2327561 October-22 2302271 April-22  14-535141 14mm 6-deg narrow 2327661 November-22 2302281 April-22  14-535142  16mm 6-deg narrow 2327691 December-22 2302291 April-22  14-535143 18 mm 6-deg narrow  2327701 December-22 2302301 April-22  14-535144  20mm 6-deg narrow 2327711 December-22 2302301 April-22  14-535144 20 mm 6-deg narrow 2302311 June-22  14-535150  12mm 12-deg narrow 2327711 December-22 2302321 April-22  14-535151 14mm 12-deg narrow 2327601 October-22 2302332 April-22   14-535152 16mm12-deg narrow  2327671 November-22 2302341 April-22  14-535153 18 mm 12-deg narrow  2327751 December-22 2302351 April-22  14-535154 20 mm 12-deg narrow 2327571 December-22 2327571 November-22 2302361 April-22  14-535170 12mm 6-deg medium  2327631 October-22 2302371 April-22  14-5351711  14 mm 6-deg medium 2327641 October-22 2302381 April-22  14-535172 16 mm 6-deg medium 2327761 December-22 2302391 April-22  14-535173  18 mm 6-deg medium  2327771 Dec 22 2302401 April 22  14-535174  20 mm 6-deg medium 2302411 April-22  14-535180 12mm 12-deg medium 2327621 October-22 2302421 April-22  14-535180 12 mm 12-deg medium 2327621 October-22 2302421 April-22  14-535182 16mm 12-deg medium 2327651 October 22 2302441 April 22  14-535183  18 mm 12-deg medium  2302451 April-22  14-535184 20 mm 12-deg medium  2327581 October-22 2302461 April-22  14-535200 12 mm 6-deg wide 2302471 April-22  14-535201  14mm 6-deg wide 2327721 December-22 2302481 April-22  14-535202  16 mm 6-deg wide  2327591 October-22 2302491 March-22  14-535203 18 mm 6-deg wide 2328311 October-22 2302501 April-12  14-535204  20 mm 6-deg wide 2302511 April-22   14-535210 12 mm 12 deg wide 2302521 April 22  14-535211 14 mm 12-deg wide 2327681 Decembr-22 2302531 April-22  14-535212 16 mm 12-deg wide 2327731 December-22 2302541 April-22  14-535213 18mm 12-deg wide 2327741 December-22 2302551 May-22
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.
  • 제품 설명
    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
  • 모델명 / 제조번호(시리얼번호)
    Part number 14-531593 Part number 14-531594  Catalog number Lot Number 14-531593 N23597  14-531594 N23599
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    Solitaire-C Cervical Spacer System || a) 14-531593 Drill/Awl Sleeve || b) 14-531594 Spring-Loaded Drill/Awl Sleeve || Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Ebi, Llc, 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA
  • 제조사 대표
    Biomedic
  • Source
    RLMPH