FDA 510(k)

Fix2Lock（生物复合材料内侧，生物复合材料外侧，生物复合材料自打孔）

K号: K202806 · 2021-06-17

决定日期2021-06-17

产品代码MAI

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

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K202806. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K202806.

When did Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) receive FDA 510(k) clearance?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) received FDA 510(k) clearance on 2021-06-17, under 510(k) number K202806.

Who is the listed applicant for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

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

What is the FDA product code for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

The FDA product code for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is MAI.

列明Osteonic Co., 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。

K254182Aster K243469SIGNEX K243470Fix2Lock（PEEK 自打孔）K243467Fix2Lock（生物复合材料内侧，生物复合材料外侧，生物复合材料自打孔）K230546SIGNEX K233659缝合翼

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