Zimmer Biomet, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 226 건

  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.
  • 제품 설명
    Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.
  • 제품 설명
    Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04
  • 모델명 / 제조번호(시리얼번호)
    Serial #'s; SP14003 and SP14005
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including France and Germany
  • 제품 설명
    Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device || The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.
  • 모델명 / 제조번호(시리얼번호)
    Serial #'s: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to AK, OH, TX, GA, and MI
  • 제품 설명
    ROSA Surgical Device 2.5.8 || ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
  • 모델명 / 제조번호(시리얼번호)
    Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France
  • 제품 설명
    ROSA Brain, 3.0.0 || The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
하나 더 221 건 더

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

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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 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.
  • 제조사 대표
    INTERMEDIC S.A.L.
  • Source
    RLMPH