FDA 510(k)

ADI TiDAL 骨切开楔形垫

K号: K191047 · 2019-11-05

申请人Additive Device, Inc. (Adi) D/B/A Restor3D

决定日期2019-11-05

产品代码PLF

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

ADI TiDAL Osteotomy Wedge is the device name listed in this FDA 510(k) record. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K191047. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADI TiDAL Osteotomy Wedge?

ADI TiDAL Osteotomy Wedge is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. The 510(k) number is K191047.

When did ADI TiDAL Osteotomy Wedge receive FDA 510(k) clearance?

ADI TiDAL Osteotomy Wedge received FDA 510(k) clearance on 2019-11-05, under 510(k) number K191047.

Who is the listed applicant for ADI TiDAL Osteotomy Wedge?

The FDA 510(k) record lists Additive Device, Inc. (Adi) D/B/A Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADI TiDAL Osteotomy Wedge?

The FDA product code for ADI TiDAL Osteotomy Wedge is PLF.

列明Additive Device, Inc. (Adi) D/B/A Restor3D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。

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