K-number	K191961
Device name	OrthoGold
Applicant	Tissue Regeneration Technologies
Product code	PZL
Device class	Class II
Decision date	Nov 26, 2019
Decision	Substantially Equivalent
Regulation	878.4685

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Source

View the full FDA submission: accessdata.fda.gov

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OrthoGold

Everything you need for a 510(k) submission. Nothing you don't.