FDA 510(k)

BonOs®注射骨水泥；NEO椎弓根螺钉系统™

K号: K222256 · 2022-08-26

决定日期2022-08-26

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 2022-08-26 under 510(k) number K222256. 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 2022-08-26. The listed applicant is Neo Medical SA. The 510(k) number is K222256.

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 2022-08-26, under 510(k) number K222256.

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™K212489BonOs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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