FDA 510(k)

BPS - 骨碎片固定板、螺钉和垫圈

K号: K250055 · 2025-02-06

决定日期2025-02-06

产品代码HRS

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

BPS - Bone Fragment Fixation Plates, Screws and Washers is the device name listed in this FDA 510(k) record. The listed applicant is Orthonovis, Inc.. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K250055. 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 BPS - Bone Fragment Fixation Plates, Screws and Washers?

BPS - Bone Fragment Fixation Plates, Screws and Washers is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Orthonovis, Inc.. The 510(k) number is K250055.

When did BPS - Bone Fragment Fixation Plates, Screws and Washers receive FDA 510(k) clearance?

BPS - Bone Fragment Fixation Plates, Screws and Washers received FDA 510(k) clearance on 2025-02-06, under 510(k) number K250055.

Who is the listed applicant for BPS - Bone Fragment Fixation Plates, Screws and Washers?

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

What is the FDA product code for BPS - Bone Fragment Fixation Plates, Screws and Washers?

The FDA product code for BPS - Bone Fragment Fixation Plates, Screws and Washers is HRS.

列明Orthonovis, 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。

K252758Cannulated Screw and Kirschner (K wire) System K250498BPS 腕部骨折系统 K242343BPS 腕部骨折系统 K213905ONX 大型外固定系统

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 固定系统Costa Surgical, Inc.K262098增强型聚醚醚酮（PEEK）拇外翻矫正系统Nvision Biomedical Technologies K262963TMC植入固定系统Treace Medical Concepts, Inc.K261647Tempo电镀系统；超压缩螺钉系统Pace Surgical K261830FRAXION 3.5 板系统（多种 - 见目录）；FRAXION 4.5 板系统（多种 - 见目录）；FRAXION 迷你板系统（多种 - 见目录）；FRAXION 骨螺钉系统（多种 - 见目录）Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock无菌敷贴系统GM 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。