FDA 510(k)

e-Ortho 肩部软件 v1.1

K号: K220758 · 2022-09-30

决定日期2022-09-30

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

e-Ortho Shoulder Software v1.1 is the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K220758. 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 e-Ortho Shoulder Software v1.1?

e-Ortho Shoulder Software v1.1 is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is FH Industrie. The 510(k) number is K220758.

When did e-Ortho Shoulder Software v1.1 receive FDA 510(k) clearance?

e-Ortho Shoulder Software v1.1 received FDA 510(k) clearance on 2022-09-30, under 510(k) number K220758.

Who is the listed applicant for e-Ortho Shoulder Software v1.1?

The FDA 510(k) record lists FH Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for e-Ortho Shoulder Software v1.1?

The FDA product code for e-Ortho Shoulder Software v1.1 is LLZ.

列明FH Industrie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。

K254003JARVIS干骺端 K253345JARVIS干骺端标准 K252411JARVIS肩胛盂反向肩关节假体 K242253JARVIS肩胛盂反向肩关节假体 K232226ARROW 肱骨插入物 K202024ARROW 短柄肱骨系统

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