FDA 510(k)

OrthoGold 100

K号: K210451 · 2021-05-05

申请人Tissue Regeneration Technologies, LLC

决定日期2021-05-05

产品代码ISA

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决定实质等同

器械摘要

OrthoGold 100 is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies, LLC. It received FDA 510(k) clearance on 2021-05-05 under 510(k) number K210451. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OrthoGold 100?

OrthoGold 100 is a medical device that received FDA 510(k) clearance on 2021-05-05. The listed applicant is Tissue Regeneration Technologies, LLC. The 510(k) number is K210451.

When did OrthoGold 100 receive FDA 510(k) clearance?

OrthoGold 100 received FDA 510(k) clearance on 2021-05-05, under 510(k) number K210451.

Who is the listed applicant for OrthoGold 100?

The FDA 510(k) record lists Tissue Regeneration Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoGold 100?

The FDA product code for OrthoGold 100 is ISA.

列明Tissue Regeneration Technologies, LLC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。

K200926OrthoGold 100

官方来源

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