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FDA 510(k)

Footmotion Plating System

K号: K161448 · 2016-10-31

申请人Newclip Technics
决定日期2016-10-31
产品代码HRS
咨询委员会OR
决定Substantially Equivalent

器械摘要

Footmotion Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K161448. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Footmotion Plating System?

Footmotion Plating System is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Newclip Technics. The 510(k) number is K161448.

When did Footmotion Plating System receive FDA 510(k) clearance?

Footmotion Plating System received FDA 510(k) clearance on 2016-10-31, under 510(k) number K161448.

Who is the listed applicant for Footmotion Plating System?

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

What is the FDA product code for Footmotion Plating System?

The FDA product code for Footmotion Plating System is HRS.

相关临床试验

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列明Newclip Technics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。

K261511Xpert AnkleK261191Alians Elbow SK261038Xpert PFPK253906Xpert HandK250767Newclip Patient-matched instrumentation non sterile PSIK250155Xpert Knee

查看所有 26 个设备 →

相关器械（代码：HRS）

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。

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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