FDA 510(k)

OrthoGold

K号: K191961 · 2019-11-26

决定日期2019-11-26

产品代码PZL

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决定实质等同

器械摘要

OrthoGold is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K191961. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OrthoGold?

OrthoGold is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Tissue Regeneration Technologies. The 510(k) number is K191961.

When did OrthoGold receive FDA 510(k) clearance?

OrthoGold received FDA 510(k) clearance on 2019-11-26, under 510(k) number K191961.

Who is the listed applicant for OrthoGold?

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

What is the FDA product code for OrthoGold?

The FDA product code for OrthoGold is PZL.

列明Tissue Regeneration Technologies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。

K182682OrthoGold 100

官方来源

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