FDA 510(k)

OLYMPIC 后路脊柱固定系统; MASADA 模块化脊柱固定系统

K号: K252885 · 2026-01-22

决定日期2026-01-22

产品代码PML

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： --- 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] --- 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

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K252885. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Astura Medical. The 510(k) number is K252885.

When did OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System receive FDA 510(k) clearance?

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252885.

Who is the listed applicant for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

The FDA 510(k) record lists Astura Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

The FDA product code for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is PML.

列明Astura Medical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。

K252346OLYMPIC 后路脊柱固定系统; MASADA 模块化脊柱固定系统 K243259MASADA Modular Spinal Fixation System K240160EGPS导航工具 K233359DOMINION可扩张椎体切除术系统 K231694MASADA Modular Spinal Fixation System K232211REUNION骶髂关节融合系统

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官方来源

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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。