FDA 510(k)

Pi Drive 2 电机 / 型号 5407-150-000，Pi Drive 2 Plus 电机 / 型号 5407-350-000

K号: K211490 · 2021-06-09

决定日期2021-06-09

产品代码ERL

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2021-06-09 under 510(k) number K211490. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000?

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 is a medical device that received FDA 510(k) clearance on 2021-06-09. The listed applicant is Stryker Corporation. The 510(k) number is K211490.

When did Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 receive FDA 510(k) clearance?

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 received FDA 510(k) clearance on 2021-06-09, under 510(k) number K211490.

Who is the listed applicant for Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000?

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

What is the FDA product code for Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000?

The FDA product code for Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 is ERL.

列明Stryker Corporation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。

K232157带有设备和语音控制的连接手术室中心，SDC4K信息管理系统 K223770Sonopet 1Q 3 7cm 1Q Large K212194Stryker Q引导系统及颅骨引导软件，CranialMask追踪器和显微镜追踪器，被动光学导航仪器，Mayfield底座带活动臂，导航活检针，电磁导航仪器，精确靶向系统 K221728Aviator® 前颈椎板（ACP）系统，LITe® 板系统，DynaTran™ 前颈椎板（ACP）系统，Reflex™ 混合ACP系统，UniVise™ 椎板固定板系统 K221074OptaBlate RF 发生器，OptaBlate 探头，OptaBlate 微注射注射装置 K221098Scopis ENT软件，Scopis ENT软件带TGS，Scopis规划软件，电磁导航单元

查看所有 42 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。