FDA 510(k)

BonOs注射骨水泥；NEO椎弓根螺钉系统

K号: K212489 · 2021-10-28

决定日期2021-10-28

产品代码PML

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

BonOs Inject Bone Cement; NEO Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Neo Medical SA. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K212489. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BonOs Inject Bone Cement; NEO Pedicle Screw System?

BonOs Inject Bone Cement; NEO Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Neo Medical SA. The 510(k) number is K212489.

When did BonOs Inject Bone Cement; NEO Pedicle Screw System receive FDA 510(k) clearance?

BonOs Inject Bone Cement; NEO Pedicle Screw System received FDA 510(k) clearance on 2021-10-28, under 510(k) number K212489.

Who is the listed applicant for BonOs Inject Bone Cement; NEO Pedicle Screw System?

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

What is the FDA product code for BonOs Inject Bone Cement; NEO Pedicle Screw System?

The FDA product code for BonOs Inject Bone Cement; NEO Pedicle Screw System is PML.

列明Neo Medical 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。

K243693NEO椎弓根螺钉系统™K222256BonOs®注射骨水泥；NEO椎弓根螺钉系统™K191796Neo笼系统 K181048Neo笼系统 TM K171582NEO椎弓根螺钉系统™

相关器械（代码：PML）

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。

K260286Dynamo® 脊柱水泥；Salvo® 脊柱系统Spine Wave, Inc.K252885OLYMPIC 后路脊柱固定系统; MASADA 模块化脊柱固定系统Astura Medical K241034Meta+ 骨水泥 & M.U.S.T. 穿刺骨盆螺钉系统Medacta International S.A.K231809Momentum®后路脊柱固定系统与G21 V-STEADY骨水泥；Momentum®微创后路脊柱固定系统与G21 V-STEADY骨水泥Ulrich Medical USA K230774PERLA® TL 系统；TEKTONA® HV US 骨水泥Spineart K222789VADER® 椎弓根系统，G21 水泥Icotec AG

官方来源

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