LimiFlex® Dynamic Sagittal Tether Instrument Set
K号: K253374 · 2026-06-16
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决定日期2026-06-16
产品代码SGL
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
LimiFlex® Dynamic Sagittal Tether Instrument Set is the device name listed in this FDA 510(k) record. The listed applicant is Empirical Spine. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253374. The device is classified under product code SGL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LimiFlex® Dynamic Sagittal Tether Instrument Set?
LimiFlex® Dynamic Sagittal Tether Instrument Set is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Empirical Spine. The 510(k) number is K253374.
When did LimiFlex® Dynamic Sagittal Tether Instrument Set receive FDA 510(k) clearance?
LimiFlex® Dynamic Sagittal Tether Instrument Set received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253374.
Who is the listed applicant for LimiFlex® Dynamic Sagittal Tether Instrument Set?
The FDA 510(k) record lists Empirical Spine as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LimiFlex® Dynamic Sagittal Tether Instrument Set?
The FDA product code for LimiFlex® Dynamic Sagittal Tether Instrument Set is SGL.
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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