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FDA 510(k)

OrthoPediatrics Locking Proximal Femur System Cortical Screws

K号: K162307 · 2016-09-27

申请人OrthoPediatrics Corp.
决定日期2016-09-27
产品代码HRS
咨询委员会OR
决定Substantially Equivalent

器械摘要

OrthoPediatrics Locking Proximal Femur System Cortical Screws is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K162307. 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 OrthoPediatrics Locking Proximal Femur System Cortical Screws?

OrthoPediatrics Locking Proximal Femur System Cortical Screws is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K162307.

When did OrthoPediatrics Locking Proximal Femur System Cortical Screws receive FDA 510(k) clearance?

OrthoPediatrics Locking Proximal Femur System Cortical Screws received FDA 510(k) clearance on 2016-09-27, under 510(k) number K162307.

Who is the listed applicant for OrthoPediatrics Locking Proximal Femur System Cortical Screws?

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 OrthoPediatrics Locking Proximal Femur System Cortical Screws?

The FDA product code for OrthoPediatrics Locking Proximal Femur System Cortical Screws is HRS.

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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。

K261345Pediatric Nailing Platform FemurK260323OrthoPediatrics® Locking Cannulated Blade Plate SystemK252600Pediatric Plating Platform I Small-MiniK251362PediFlex™ Flexible Nail SystemK243963Pediatric Plating Platform HipK250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur

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

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