FDA 510(k)

NextAR (™) 肩关节平台

K号: K251737 · 2025-09-04

决定日期2025-09-04

产品代码SBF

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决定实质等同

器械摘要

NextAR(TM) Shoulder Platform is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251737. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NextAR(TM) Shoulder Platform?

NextAR(TM) Shoulder Platform is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Medacta International S.A.. The 510(k) number is K251737.

When did NextAR(TM) Shoulder Platform receive FDA 510(k) clearance?

NextAR(TM) Shoulder Platform received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251737.

Who is the listed applicant for NextAR(TM) Shoulder Platform?

FDA 510(k)记录将Medacta International S.A.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for NextAR(TM) Shoulder Platform?

The FDA product code for NextAR(TM) Shoulder Platform is SBF.

列明Medacta International S.A.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。

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