快速手术计划（RSP-SW-001）
K号: K243447 · 2024-12-05
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器械摘要
Rapid Surgical Plan (RSP-SW-001) is the device name listed in this FDA 510(k) record. The listed applicant is Navbit Pty, Ltd.. It received FDA 510(k) clearance on 2024-12-05 under 510(k) number K243447. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Rapid Surgical Plan (RSP-SW-001)?
Rapid Surgical Plan (RSP-SW-001) is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Navbit Pty, Ltd.. The 510(k) number is K243447.
When did Rapid Surgical Plan (RSP-SW-001) receive FDA 510(k) clearance?
Rapid Surgical Plan (RSP-SW-001) received FDA 510(k) clearance on 2024-12-05, under 510(k) number K243447.
Who is the listed applicant for Rapid Surgical Plan (RSP-SW-001)?
The FDA 510(k) record lists Navbit Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rapid Surgical Plan (RSP-SW-001)?
The FDA product code for Rapid Surgical Plan (RSP-SW-001) is LLZ.
相关临床试验
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列明Navbit Pty, Ltd.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。
相关器械（代码：LLZ）
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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请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
官方来源
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