OrthoGold 100
K-Number: K200926 · 2020-08-28
Decision Date2020-08-28
Product CodePZL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
OrthoGold 100 is a medical device manufactured by Tissue Regeneration Technologies, LLC. It received FDA 510(k) clearance on 2020-08-28 under approval number K200926. 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 100?
OrthoGold 100 is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Tissue Regeneration Technologies, LLC. The 510(k) number is K200926.
When was OrthoGold 100 approved by the FDA?
OrthoGold 100 received FDA 510(k) clearance on 2020-08-28, under approval number K200926.
What company makes OrthoGold 100?
OrthoGold 100 is manufactured by Tissue Regeneration Technologies, LLC.
What is the FDA product code for OrthoGold 100?
The FDA product code for OrthoGold 100 is PZL.
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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.