FDA 510(k)

ExactechGPS 全肩应用，Equinoxe 计划软件

K号: K213546 · 2022-01-06

决定日期2022-01-06

产品代码OLO

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决定实质等同

器械摘要

ExactechGPS Total Shoulder Application, Equinoxe Planning Software is the device name listed in this FDA 510(k) record. The listed applicant is Blue Ortho. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K213546. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ExactechGPS Total Shoulder Application, Equinoxe Planning Software?

ExactechGPS Total Shoulder Application, Equinoxe Planning Software is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Blue Ortho. The 510(k) number is K213546.

When did ExactechGPS Total Shoulder Application, Equinoxe Planning Software receive FDA 510(k) clearance?

ExactechGPS Total Shoulder Application, Equinoxe Planning Software received FDA 510(k) clearance on 2022-01-06, under 510(k) number K213546.

Who is the listed applicant for ExactechGPS Total Shoulder Application, Equinoxe Planning Software?

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

What is the FDA product code for ExactechGPS Total Shoulder Application, Equinoxe Planning Software?

The FDA product code for ExactechGPS Total Shoulder Application, Equinoxe Planning Software is OLO.

列明Blue Ortho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。

K233299ExactechGPS® 系统 K232521ExactechGPS® 全踝应用 K213877ExactechGPS® 系统 K193618ExactechGPS 系统 K173372ExactechGPS 全肩应用 K162567ExactechGPS 全肩应用，Equinoxe 计划软件

查看所有 8 个设备 →

官方来源

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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。