FDA 510(k)

Acorn 3D 软件（AC-SEG-4009）；Acorn 3DP 模型（AC-101-XX）

K号: K260322 · 2026-06-11

决定日期2026-06-11

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is the device name listed in this FDA 510(k) record. The listed applicant is Mighty Oak Medical. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K260322. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)?

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Mighty Oak Medical. The 510(k) number is K260322.

When did Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) receive FDA 510(k) clearance?

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K260322.

Who is the listed applicant for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)?

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

What is the FDA product code for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)?

The FDA product code for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is QIH.

列明Mighty Oak Medical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。

K253472FIREFLY® 椎弓根螺钉导航引导器 K252103Acorn 3D 软件（AC-SEG-4009）；Acorn 3DP 模型（AC-101-XX）K251532Acorn 3D 软件（AC-SEG-4009）；Acorn 3DP 模型（AC-101-XX）K234009Acorn 3D 软件（AC-SEG-4009）；Acorn 3DP 模型（AC-101-XX）

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。