FDA 510(k)

UNiD™ 脊柱分析仪（SW3002）

K号: K261289 · 2026-05-15

申请人Medicrea International S.A.S. (Medtronic)

决定日期2026-05-15

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

UNiD™ Spine Analyzer (SW3002) is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International S.A.S. (Medtronic). It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K261289. 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 UNiD™ Spine Analyzer (SW3002)?

UNiD™ Spine Analyzer (SW3002) is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Medicrea International S.A.S. (Medtronic). The 510(k) number is K261289.

When did UNiD™ Spine Analyzer (SW3002) receive FDA 510(k) clearance?

UNiD™ Spine Analyzer (SW3002) received FDA 510(k) clearance on 2026-05-15, under 510(k) number K261289.

Who is the listed applicant for UNiD™ Spine Analyzer (SW3002)?

The FDA 510(k) record lists Medicrea International S.A.S. (Medtronic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNiD™ Spine Analyzer (SW3002)?

The FDA product code for UNiD™ Spine Analyzer (SW3002) is QIH.

列明Medicrea International S.A.S. (Medtronic)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。

K253577IB3D™ 脊柱系统（A24000000 / IB3D通用植入物插入器）K251629UNiD™ 脊柱分析仪 K241164IB3D™ 脊柱系统

官方来源

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