Reverse Shoulder Prosthesis System

  • 모델명 / 제조번호(시리얼번호)
    Model Number 508-00-000: lot #s: 848C1078, 848C1079, 848C1080, 848C1081, 848C1082, 848C1083, 848C1084, 848C1085, 848C1086, 848C1087  Model number: 508-00-008, lot #'s: 854C1016
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, LA, MA, MD, ME, NM, NY, OK, PA, SC, TN, TX, UT, and WA and the countries of Germany, Italy, and United Kingdom.
  • 제품 설명
    Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. || The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA