骨科手术规划软件 (AIJOINT)
K号: K233761 · 2024-08-05
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器械摘要
Orthopaedic Surgery Planning Software (AIJOINT) is the device name listed in this FDA 510(k) record. The listed applicant is Longwood Valley Medical , Ltd.. It received FDA 510(k) clearance on 2024-08-05 under 510(k) number K233761. 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 Orthopaedic Surgery Planning Software (AIJOINT)?
Orthopaedic Surgery Planning Software (AIJOINT) is a medical device that received FDA 510(k) clearance on 2024-08-05. The listed applicant is Longwood Valley Medical , Ltd.. The 510(k) number is K233761.
When did Orthopaedic Surgery Planning Software (AIJOINT) receive FDA 510(k) clearance?
Orthopaedic Surgery Planning Software (AIJOINT) received FDA 510(k) clearance on 2024-08-05, under 510(k) number K233761.
Who is the listed applicant for Orthopaedic Surgery Planning Software (AIJOINT)?
The FDA 510(k) record lists Longwood Valley Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Orthopaedic Surgery Planning Software (AIJOINT)?
The FDA product code for Orthopaedic Surgery Planning Software (AIJOINT) is LLZ.
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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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