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FDA 510(k)

Stryker 定制下颌骨重建板；Stryker 外科医生 iD 下颌骨重建板

K号: K222650 · 2022-12-09

申请人Stryker Craniomaxillofacial (Cmf)
决定日期2022-12-09
产品代码JEY
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决定实质等同

器械摘要

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Craniomaxillofacial (Cmf). It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222650. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Stryker Craniomaxillofacial (Cmf). The 510(k) number is K222650.

When did Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate receive FDA 510(k) clearance?

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222650.

Who is the listed applicant for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

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

What is the FDA product code for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

The FDA product code for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is JEY.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：JEY）

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。

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官方来源

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