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FDA 510(k)

Ulna Plating System

K号: K162424 · 2016-10-12

申请人Biomet, Inc.
决定日期2016-10-12
产品代码HRS
咨询委员会OR
决定Substantially Equivalent

器械摘要

Ulna Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K162424. 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 Ulna Plating System?

Ulna Plating System is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Biomet, Inc.. The 510(k) number is K162424.

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

Ulna Plating System received FDA 510(k) clearance on 2016-10-12, under 510(k) number K162424.

Who is the listed applicant for Ulna Plating System?

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

What is the FDA product code for Ulna Plating System?

The FDA product code for Ulna Plating System is HRS.

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列明Biomet, Inc.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。

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

查看所有 36 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 →

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