免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

KLS Martin 颅骨植入物 - MR 条件；K944565：KLS-Martin 微型骨合成系统（1.5MM）；K971297：KLS Martin 中心驱动无钻螺丝；K060177：KLS Martin 刚性固定 - 无菌；K062570：个体化患者解决方案 - Ti (IPS-Ti)；K072707：个体化患者解决方案 - PEEK (IPS-PEEK)；K151382：个体化患者解决方案 - (IPS-PEEK) - 无菌

K号: K252573 · 2025-11-10

申请人KLS-Martin L.P.
决定日期2025-11-10
产品代码GXN
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 2025-11-10 under 510(k) number K252573. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE?

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE is a medical device that received FDA 510(k) clearance on 2025-11-10. The listed applicant is KLS-Martin L.P.. The 510(k) number is K252573.

When did KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE receive FDA 510(k) clearance?

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE received FDA 510(k) clearance on 2025-11-10, under 510(k) number K252573.

Who is the listed applicant for KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE?

FDA 510(k)记录中列出KLS-Martin L.P.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 KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE?

The FDA product code for KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE is GXN.

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KLS-Martin L.P.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。

K260137KLS Martin IPS 口腔-Max 种植体 - MR 条件性；个体化患者解决方案 - Ti (IPS-Ti)；个体化患者解决方案 - PEEK (IPS-PEEK)；KLS Martin 个体化患者解决方案K253660KLS Martin Pure Pectus 系统K254162KLS Martin Ixos 系统K250988KLS Martin Pure Pectus 系统K250865KLS Martin IPS 前臂系统K250620KLS Martin Ixos 系统

查看所有 33 个设备 →

相关器械（代码：GXN）

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。

K260709ClearFit Ti 环 14mm (171750)；ClearFit Ti 环 14mm 带槽 (171751)；ClearFit Ti 环 20mm (171752)；ClearFit Ti 环 20mm 带槽 (171753)；ClearFit Ti 环 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC 钛颅骨板 (TCP) 系统The Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY 定制钛网状植入物Meticuly Co., Ltd.K243715Synthes患者特异性植入物Synthes GmbHK240567定制骨服务Fin-Ceramica Faenza S.P.A.

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。

↑