假肢，棘突间隙/板
PMA编号：P240043 · 2026-04-01
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决定日期2026-04-01
PMA 编号P240043
产品代码NQO
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
Prosthesis, spinous process spacer/plate is the device name listed in this FDA 510(k) record. The listed applicant is Companion Spine France Sas. It received FDA 510(k) clearance on 2026-04-01. The device is classified under product code NQO. It was reviewed by the OR advisory panel. Product code NQO falls under the category of General Hospital, which covers general-purpose hospital equipment and supplies. Devices in this category are subject to specific FDA regulatory requirements.
常见问题
What is the Prosthesis, spinous process spacer/plate?
Prosthesis, spinous process spacer/plate is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Companion Spine France Sas.
When did Prosthesis, spinous process spacer/plate receive FDA 510(k) clearance?
The clearance date for Prosthesis, spinous process spacer/plate can be found in the official FDA records.
Who is the listed applicant for Prosthesis, spinous process spacer/plate?
The FDA 510(k) record lists Companion Spine France Sas as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Prosthesis, spinous process spacer/plate?
The FDA product code for Prosthesis, spinous process spacer/plate is NQO. This falls under the General Hospital category.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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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