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FDA 510(k)

OrthoGold

K-Number: K191961 · 2019-11-26

ApplicantTissue Regeneration Technologies
Decision Date2019-11-26
Product CodePZL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OrthoGold is a medical device manufactured by Tissue Regeneration Technologies. It received FDA 510(k) clearance on 2019-11-26 under approval number K191961. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoGold?

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

When was OrthoGold approved by the FDA?

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

What company makes OrthoGold?

OrthoGold is manufactured by Tissue Regeneration Technologies.

What is the FDA product code for OrthoGold?

The FDA product code for OrthoGold is PZL.

Other Devices by Tissue Regeneration Technologies

K182682OrthoGold 100

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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