儿童接骨平台 股骨
K号: K261345 · 2026-09-24
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器械摘要
Pediatric Nailing Platform Femur is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K261345. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pediatric Nailing Platform Femur?
Pediatric Nailing Platform Femur is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K261345.
When did Pediatric Nailing Platform Femur receive FDA 510(k) clearance?
Pediatric Nailing Platform Femur received FDA 510(k) clearance on 2026-09-24, under 510(k) number K261345.
Who is the listed applicant for Pediatric Nailing Platform Femur?
The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pediatric Nailing Platform Femur?
The FDA product code for Pediatric Nailing Platform Femur is HSB.
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。
列明OrthoPediatrics Corp.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。
相关器械（代码：HSB）
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。
K261481Pangea股骨重建系统Stryker GmbHK253080AND 医疗股骨钉系统（PFNA01）；AND 医疗股骨钉系统（PFNA02）Suzhou and Science & Technology Development Corp.K261651Precice® Max System and Precice® Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155富乐金属锁定髓内钉系统Beijing Fule Science & Technology Development Co., Ltd.K253046HERA 齿锁髓内钉系统ZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® 运输和延长系统Orthofix Srl
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。
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