FDA 510(k)

PASS LP™ 脊柱系统，CD Horizon™ 脊柱系统

K号: K213281 · 2022-01-05

决定日期2022-01-05

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

PASS LP™ Spinal System, CD Horizon™ Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K213281. 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 PASS LP™ Spinal System, CD Horizon™ Spinal System?

PASS LP™ Spinal System, CD Horizon™ Spinal System is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Medicrea International SA. The 510(k) number is K213281.

When did PASS LP™ Spinal System, CD Horizon™ Spinal System receive FDA 510(k) clearance?

PASS LP™ Spinal System, CD Horizon™ Spinal System received FDA 510(k) clearance on 2022-01-05, under 510(k) number K213281.

Who is the listed applicant for PASS LP™ Spinal System, CD Horizon™ Spinal System?

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

What is the FDA product code for PASS LP™ Spinal System, CD Horizon™ Spinal System?

The FDA product code for PASS LP™ Spinal System, CD Horizon™ Spinal System is NKB.

列明Medicrea International SA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。

K213659LigaPASS™ 2.0 韧带增强系统 K210470C-CURVE椎间融合装置 K200316UNiD IB3D ALIF K191134IB3D ALIF K182158UNiD 患者匹配 PLIF 置入笼 K190092UNiD 患者定制 3D 打印 TLIF 置换笼

查看所有 21 个设备 →

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

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。