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FDA 510(k)

mGRIP部分义肢(0.75毫米)(58669);mGRIP部分义肢(1.00毫米)(58671);mGRIP部分义肢(1.25毫米)(58673);mGRIP部分义肢(1.50毫米)(58675);mGRIP部分义肢(1.75毫米)(58677);mGRIP部分义肢(2.00毫米)(58679);mGRIP部分义肢(2.25毫米)(58681);mGRIP部分义肢(2.50毫米)(58683);mGRIP部分义肢(3.00毫米)(58685);mGRIP部分义肢(3.50毫米)(58687);mDISC部分义肢(58850)

K号: K260718 · 2026-04-03

决定日期2026-04-03
产品代码ETB
咨询委员会医疗设备监管文本描述翻译如下: 关于[公司/产品名称]的监管信息: - 美国食品药品监督管理局(FDA)批准号:[510(k)编号] - 预市场批准(PMA)申请号:[PMA编号] - 临床试验注册号(NCT):[NCT编号] - 医学文献标识符(PMID):[PMID编号] - 产品标识符:[标识符] - 相关政策:医疗监管政策v1 - 更多信息请访问:[URL] 请注意,以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。
决定实质等同

器械摘要

mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) is the device name listed in this FDA 510(k) record. The listed applicant is MED-EL Elektromedizinische Geräte GmbH. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K260718. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)?

mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is MED-EL Elektromedizinische Geräte GmbH. The 510(k) number is K260718.

When did mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) receive FDA 510(k) clearance?

mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) received FDA 510(k) clearance on 2026-04-03, under 510(k) number K260718.

Who is the listed applicant for mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)?

The FDA 510(k) record lists MED-EL Elektromedizinische Geräte GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)?

The FDA product code for mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) is ETB.

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。

列明MED-EL Elektromedizinische Geräte GmbH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。

K260719mGRIP 全髋关节假体(3.00毫米)(58689);mGRIP 全髋关节假体(3.25毫米)(58691);mGRIP 全髋关节假体(3.50毫米)(58693);mGRIP 全髋关节假体(3.75毫米)(58695);mGRIP 全髋关节假体(4.00毫米)(58697);mGRIP 全髋关节假体(4.25毫米)(58699);mGRIP 全髋关节假体(4.50毫米)(58701);mGRIP 全髋关节假体(4.75毫米)(58703);mGRIP 全髋关节假体(5.00毫米)(58705);mGRIP 全髋关节假体(5.50毫米)(58707);mGRIP 全髋关节假体(6.00毫米)(58709);mGRIP 全髋关节假体(6.50毫米)K260720mWING 骨底板假体(0.4 x 3.50 mm)(58717);mWING 骨底板假体(0.4 x 3.75 mm)(58719);mWING 骨底板假体(0.4 x 4.00 mm)(58721);mWING 骨底板假体(0.4 x 4.25 mm)(58723);mWING 骨底板假体(0.4 x 4.50 mm)(58725);mWING 骨底板假体(0.4 x 4.75 mm)(58727);mWING 骨底板假体(0.4 x 5.00 mm)(58729);mWING 骨底板假体(0.4 x 5.25 mm)(58731);mWING 骨底板假体(0.4 x 5.50 mm)(58733);mWING 骨底板假体(0.5 x 3.50 mm)(58735);K241261mCLIP 部分义肢,mCLIP ARC 部分义肢,mXACT 部分义肢和 mXACT PRO 部分义肢套装K241142mAXIS 骨底板假体,mLOOP 骨底板假体,mZAM 骨底板假体和 mFIX 骨底板假体K241269mXACT 全髋关节假体偏心组件,mXACT 全髋关节假体中心组件和 mXACT PRO 全髋关节假体套装

相关器械(代码:ETB)

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。

官方来源

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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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