FDA 510(k)

Southern 前部螺丝固定笼 (SASCA)

K号: K221447 · 2022-10-14

决定日期2022-10-14

产品代码OVD

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

Southern Anterior Screw Fixated Cage (SASCA) is the device name listed in this FDA 510(k) record. The listed applicant is Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221447. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Southern Anterior Screw Fixated Cage (SASCA)?

Southern Anterior Screw Fixated Cage (SASCA) is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Southern Medical (Pty) , Ltd.. The 510(k) number is K221447.

When did Southern Anterior Screw Fixated Cage (SASCA) receive FDA 510(k) clearance?

Southern Anterior Screw Fixated Cage (SASCA) received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221447.

Who is the listed applicant for Southern Anterior Screw Fixated Cage (SASCA)?

The FDA 510(k) record lists Southern Medical (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Southern Anterior Screw Fixated Cage (SASCA)?

The FDA product code for Southern Anterior Screw Fixated Cage (SASCA) is OVD.

列明Southern Medical (Pty) , Ltd.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。

K253373Southern 颅面 (CMF) 系统 K230607SPICCA 颈椎融合笼 K230608SPICCA 独立颈椎融合笼 K231145Axis Anterior Cervical Plate System K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)

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。