FDA 510(k)

DSM 生物医学磷酸钙水泥

K号: K173362 · 2018-04-03

申请人Kensey Nash Corporation Dba Dsm Biomedical

决定日期2018-04-03

产品代码MQV

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

DSM Biomedical Calcium Phosphate Cement is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K173362. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DSM Biomedical Calcium Phosphate Cement?

DSM Biomedical Calcium Phosphate Cement is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. The 510(k) number is K173362.

When did DSM Biomedical Calcium Phosphate Cement receive FDA 510(k) clearance?

DSM Biomedical Calcium Phosphate Cement received FDA 510(k) clearance on 2018-04-03, under 510(k) number K173362.

Who is the listed applicant for DSM Biomedical Calcium Phosphate Cement?

The FDA 510(k) record lists Kensey Nash Corporation Dba Dsm Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSM Biomedical Calcium Phosphate Cement?

The FDA product code for DSM Biomedical Calcium Phosphate Cement is MQV.

列明Kensey Nash Corporation Dba Dsm Biomedical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。

K173572DSM Biomedical 磷酸钙水泥微球 K170245DSM Biomedical 牙科骨移植 K160474DSM Biomedical 猪心包牙膜

相关器械（代码：MQV）

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。

K262230Mg OSTEOREVIVE™；Mg OSTEOCRETE™Bone Solutions, Inc.K260364设备300419条带Geistlich Pharma AG K252797JAZBI®可吸收骨空隙填充剂Sdip Innovations Pty, Ltd.K261008Vitoss® 双模态生物活性骨移植替代泡沫条；Vitoss® 双模态生物活性骨移植替代品；Vitoss BBTrauma® 生物活性骨移植替代品；Vitoss® BA2X 生物活性骨移植替代品；Vitoss® 生物活性泡沫骨移植替代品套装；Vitoss® 生物活性泡沫骨移植替代品；Vitoss® 泡沫骨移植替代品；Vitoss® 骨移植替代品填充罐；Vitoss® 骨移植替代品Stryker Spine K253524Adaptos®Fuse Bone GraftBiomendex OY K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.

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。