FDA 510(k)

7D手术系统 - 钻孔引导

K号: K210555 · 2021-03-23

决定日期2021-03-23

产品代码OLO

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

7D Surgical System - Drill Guide is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical, Inc.. It received FDA 510(k) clearance on 2021-03-23 under 510(k) number K210555. 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 7D Surgical System - Drill Guide?

7D Surgical System - Drill Guide is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K210555.

When did 7D Surgical System - Drill Guide receive FDA 510(k) clearance?

7D Surgical System - Drill Guide received FDA 510(k) clearance on 2021-03-23, under 510(k) number K210555.

Who is the listed applicant for 7D Surgical System - Drill Guide?

The FDA 510(k) record lists 7D Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical System - Drill Guide?

The FDA product code for 7D Surgical System - Drill Guide is OLO.

列明7D Surgical, Inc.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。

K2104577D注册框架，7D Flex髂骨连接器，7D针引导块，7D 3.2 mm Steinmann针，7D髂嵴针夹与钥匙 K2019667D手术FlashLock 1，7D手术Flex杆连接器 - 5.5 mm - 150 mm，7D手术Flex阵列 K1929457D手术系统颅部活检和心室导管放置应用 K1921407D手术系统 K1832767D手术系统 K1810417D手术系统颅部应用

查看所有 9 个设备 →

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。