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FDA 510(k)

XIA® 4.5 脊柱系统，XIA® 4.5 皮层轨迹，XIA® 3 脊柱系统，Serrato® 脊柱系统，XIA® 成长棒转换套件，XIA® II 脊柱系统，XIA® 精准系统，XIA® 前部，Diapason® 脊柱系统，Opus™ 脊柱系统，Radius® 脊柱系统，Mantis® 脊柱系统，Mantis® Redux，Trio® & Trio+ 脊柱固定系统，ES2™ 脊柱系统，ES2™ 可扩展脊柱系统，Oasys® 枕颈胸系统，Nile® 近端固定脊柱系统，Nile® 替代固定脊柱系统

K号: K222684 · 2023-06-08

申请人Stryker Spine
决定日期2023-06-08
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

XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Spine. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K222684. 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 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi?

XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Stryker Spine. The 510(k) number is K222684.

When did XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi receive FDA 510(k) clearance?

XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi received FDA 510(k) clearance on 2023-06-08, under 510(k) number K222684.

Who is the listed applicant for XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi?

FDA 510(k)记录显示Stryker Spine为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi?

The FDA product code for XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi is NKB.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Stryker Spine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。

K262061Tritanium® C 前颈椎笼；Tritanium® PL笼；Tritanium® TL弯曲腰椎笼；Aero® -C 颈椎笼系统；AVS® Anchor-C 颈椎笼系统；AVS® TL PEEK间隔器；AVS® PL PEEK间隔器；AVS® 导航PEEK间隔器；AVS® AS PEEK间隔器；Monterey™ AL椎间系统；Aleutian IBF系统；Cascadia椎间系统；Chesapeake稳定系统；Sahara稳定系统；SANTORINI™ 脱位椎体笼系统；MOJAVE椎间系统；VLIFT VERTEBRAL BODY REPLACEMK261008Vitoss® 双模态生物活性骨移植替代泡沫条；Vitoss® 双模态生物活性骨移植替代品；Vitoss BBTrauma® 生物活性骨移植替代品；Vitoss® BA2X 生物活性骨移植替代品；Vitoss® 生物活性泡沫骨移植替代品套装；Vitoss® 生物活性泡沫骨移植替代品；Vitoss® 泡沫骨移植替代品；Vitoss® 骨移植替代品填充罐；Vitoss® 骨移植替代品K242361OZARK 颈椎板系统；PYRENEES® 颈椎板系统；EVEREST® 脊柱系统；MESA® 脊柱系统；MESA® 小体型脊柱系统；CASPIAN® 脊柱系统；DENALI® 脊柱系统；DENALI® MI 脊柱系统；YUKON OCT 脊柱系统；Xia® 3 脊柱系统；K2M 病人专用；CASCADIA™ 椎间系统；CAYMAN® 板系统；CAYMAN® 板系统-MIK242280Vitoss® 双模态生物活性骨移植替代泡沫条，Vitoss® 双模态生物活性骨移植替代品，Vitoss BBTrauma® 生物活性骨移植替代品，Vitoss® BA2X 生物活性骨移植替代品，Vitoss® 生物活性骨移植替代品套装，Vitoss® 生物活性骨移植替代品，Vitoss® 泡沫骨移植替代品，Vitoss® 骨移植替代品填充罐，Vitoss® 骨移植替代品，Vitoss® 骨移植替代品 - 合成多孔片K221490Tritanium C 前颈椎笼，Tritanium PL笼，Tritanium TL弯曲后腰椎笼，Tritanium X PL可扩张后腰椎笼，Tritanium X TL可扩张弯曲后腰椎笼，Stryker Spine VLIFT 脊椎体置换系统，VLIFT-s 脊椎体置换系统，Ascential IBD PEEKc 间隔器，Aero-AL 腰椎笼系统，Aero-LL 腰椎笼系统，Aero-C 颈椎笼系统，AVS Aria PEEK 间隔器，AVS Anchor-C 颈椎笼系统，AVS Anchor-L 间隔器K203205导航脊柱器械

查看所有 13 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 SirketiK262193RIVA® 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 MedicalK262828KHEIRON®脊柱固定系统，包括患者专用K-RODS.M.A.I.OK260362QUATTRO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。

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