FDA 510(k)

TalisMann 神经调节系统

K号: K243678 · 2025-07-03

决定日期2025-07-03

产品代码GZF

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决定实质等同

器械摘要

TalisMann Neuromodulation System is the device name listed in this FDA 510(k) record. The listed applicant is Bioventus, LLC. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K243678. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TalisMann Neuromodulation System?

TalisMann Neuromodulation System is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Bioventus, LLC. The 510(k) number is K243678.

When did TalisMann Neuromodulation System receive FDA 510(k) clearance?

TalisMann Neuromodulation System received FDA 510(k) clearance on 2025-07-03, under 510(k) number K243678.

Who is the listed applicant for TalisMann Neuromodulation System?

FDA 510(k)记录中列出Bioventus, LLC为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for TalisMann Neuromodulation System?

The FDA product code for TalisMann Neuromodulation System is GZF.

列明Bioventus, LLC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。

K253877StimTrial 神经调节系统 K243782StimTrial 神经调节系统 K233368同种异体移植物输送装置（OFAC-C）K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty K162860MCS 骨移植

官方来源

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