IntraOp 对位系统；CONTOUR3D 弯曲系统
K号: K253216 · 2026-06-25
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决定日期2026-06-25
产品代码SIN
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。
决定实质等同
器械摘要
IntraOp Alignment System; CONTOUR3D Bending System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253216. The device is classified under product code SIN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IntraOp Alignment System; CONTOUR3D Bending System?
IntraOp Alignment System; CONTOUR3D Bending System is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K253216.
When did IntraOp Alignment System; CONTOUR3D Bending System receive FDA 510(k) clearance?
IntraOp Alignment System; CONTOUR3D Bending System received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253216.
Who is the listed applicant for IntraOp Alignment System; CONTOUR3D Bending System?
FDA 510(k)记录将Alphatec Spine, Inc.列为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for IntraOp Alignment System; CONTOUR3D Bending System?
The FDA product code for IntraOp Alignment System; CONTOUR3D Bending System is SIN.
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。
列明Alphatec Spine, Inc.为申报人的其他记录
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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