ConforMIS, Inc.

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  • 모델명 / 제조번호(시리얼번호)
    Serial Number: 0384180
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution to TX only
  • 제품 설명
    ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT || Catalog Number:TPS-111-1111 || The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed to the states of CO and NV.
  • 제품 설명
    ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile || Catalog Number: TCR-111-1111. || Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use || of a prosthetic device.
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to the states of :CA and TX.
  • 제품 설명
    Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ || Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: OUS 0354195
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed Nationwide and in Germany, Switzerland, and UK.
  • 제품 설명
    ConFormis iDUO G2, Right Lateral || Catalog Number: M5723INT0600240 (US) || M5723INT0600240 (OUS)
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers (US): Left: 0353417 0353616 0354944 0353554 0348951 0354052 0351267 0352723 0353063 0353116 0352223 0351354 0353685 0354118 0354573 0351678 0354306 0355213 0354531 0352895 0353969 0354670 0352804 0353375 0353584 0353955 0353394 0354457 0354251 0354470 0353392 0351881 0353596 0352702 0354028 0354049 0352925 0354005 0354115 0354863 0352181 0354089 0353451 0354720 0352945 0353262 0353662 0353269  Right:: 0353557 0354179 0350279 0355149 0353833 0353430 0353480 0353628 0354373 0352045 0353346 0350509 0352556 0353120 0353287 0353535 0354487 0354691 0351677 0354706 0353997 0354119 0353421 0353585 0353580 0353617 0354393 0354940 0353390 0353634 0353720 0354226 0353080 0353372 0353096 0354048 0354050 0354054 0354947 0353806 0354257 0354478 0354938 0355240 0354063 0352352 0353728 0353725 0354430 0353278 0353433 0353810 0352946 0353664 0353665 0354247  Serial Numbers: (OUS) iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250 ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed Nationwide and in Germany, Switzerland, and UK.
  • 제품 설명
    ConFormis iTotal Posterior Stabilized Knee Replacement System- || ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and || ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT || Catalog Number:TPS1111111
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