FDA 510(k)

Pedimax II - 椎弓根螺钉脊柱系统

K号: K180626 · 2019-02-01

申请人Gm Dos Reis Industria E Comerico Ltda.

决定日期2019-02-01

产品代码NKB

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

Pedimax II - Pedicular Screw Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Gm Dos Reis Industria E Comerico Ltda.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K180626. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pedimax II - Pedicular Screw Spinal System?

Pedimax II - Pedicular Screw Spinal System is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Gm Dos Reis Industria E Comerico Ltda.. The 510(k) number is K180626.

When did Pedimax II - Pedicular Screw Spinal System receive FDA 510(k) clearance?

Pedimax II - Pedicular Screw Spinal System received FDA 510(k) clearance on 2019-02-01, under 510(k) number K180626.

Who is the listed applicant for Pedimax II - Pedicular Screw Spinal System?

The FDA 510(k) record lists Gm Dos Reis Industria E Comerico Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pedimax II - Pedicular Screw Spinal System?

The FDA product code for Pedimax II - Pedicular Screw Spinal System is NKB.

列明Gm Dos Reis Industria E Comerico Ltda.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。

K223114缝合锚 - HTA无头钛锚和Zip锚 K182718微型和微型碎片重建系统 - GMReis

相关器械（代码：NKB）

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。

K252139肯特罗斯宾 Viktr-MIS® 椎弓根螺钉系统Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™植入系统SI-BONE, Inc.K262091FRAXION 脊柱固定系统Ortler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® 后固定系统，配备NanoACTIV表面技术；RIVA® 锚定骶髂固定系统，配备NanoACTIV表面技术Xenix Medical K262828KHEIRON®脊柱固定系统，包括患者专用K-RODS.M.A.I.O K260362QUATTRO脊柱系统（开放配置）；QUATTRO-GADGET脊柱系统（微创配置）MANTIZ Co., Ltd.

官方来源

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