用于康复股骨截肢者的Osseoanchored假肢
PMA编号：P190009 · 2026-04-15
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申请人Integrum AB
决定日期2026-04-15
PMA 编号P190009
产品代码PJY
设备分类第3类
医疗专科U
咨询委员会OR
请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整：
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产品名称：[产品名称]
公司名称：[公司名称]
根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。
产品注册号：[注册号]
PMA编号：[PMA编号]
临床试验编号（NCT）：[NCT编号]
PubMed ID（PMID）：[PMID编号]
更多信息请访问以下链接：
[URL]
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请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
器械摘要
Osseoanchored prostheses for the rehabilitation of transfemoral amputees is the device name listed in this FDA 510(k) record. The listed applicant is Integrum AB. It received FDA 510(k) clearance on 2026-04-15. The device is classified under product code PJY. It was reviewed by the OR advisory panel.
常见问题
What is the Osseoanchored prostheses for the rehabilitation of transfemoral amputees?
Osseoanchored prostheses for the rehabilitation of transfemoral amputees is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Integrum AB.
When did Osseoanchored prostheses for the rehabilitation of transfemoral amputees receive FDA 510(k) clearance?
The clearance date for Osseoanchored prostheses for the rehabilitation of transfemoral amputees can be found in the official FDA records.
Who is the listed applicant for Osseoanchored prostheses for the rehabilitation of transfemoral amputees?
The FDA 510(k) record lists Integrum AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Osseoanchored prostheses for the rehabilitation of transfemoral amputees?
The FDA product code for Osseoanchored prostheses for the rehabilitation of transfemoral amputees is PJY.
相关临床试验
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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