FDA 510(k)

同种异体移植物输送装置（OFAC-C）

K号: K233368 · 2024-06-25

决定日期2024-06-25

产品代码FMF

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Allograft Delivery Device (OFAC-C) is the device name listed in this FDA 510(k) record. The listed applicant is Bioventus, LLC. It received FDA 510(k) clearance on 2024-06-25 under 510(k) number K233368. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Allograft Delivery Device (OFAC-C)?

Allograft Delivery Device (OFAC-C) is a medical device that received FDA 510(k) clearance on 2024-06-25. The listed applicant is Bioventus, LLC. The 510(k) number is K233368.

When did Allograft Delivery Device (OFAC-C) receive FDA 510(k) clearance?

Allograft Delivery Device (OFAC-C) received FDA 510(k) clearance on 2024-06-25, under 510(k) number K233368.

Who is the listed applicant for Allograft Delivery Device (OFAC-C)?

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 Allograft Delivery Device (OFAC-C)?

The FDA product code for Allograft Delivery Device (OFAC-C) is FMF.

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 K243678TalisMann 神经调节系统 K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty K162860MCS 骨移植

相关器械（代码：FMF）

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。

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官方来源

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