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FDA 510(k)

EVEREST 脊柱系统，RANGE（MESA 和 DENALI）脊柱系统，CASPIAN OCT（MESA Mini 和 DENALI Mini）脊柱系统，YUKON OCT 脊柱系统

K号: K181603 · 2018-10-05

申请人K2m, Inc.
决定日期2018-10-05
产品代码NKG
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

EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2018-10-05 under 510(k) number K181603. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System?

EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System is a medical device that received FDA 510(k) clearance on 2018-10-05. The listed applicant is K2m, Inc.. The 510(k) number is K181603.

When did EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System receive FDA 510(k) clearance?

EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System received FDA 510(k) clearance on 2018-10-05, under 510(k) number K181603.

Who is the listed applicant for EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System?

The FDA product code for EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System is NKG.

相关临床试验

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官方来源

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