Name: Predicase
Price: 199 USD

K-number	K182609
Device name	Delphos Implants Rigid Fixation System
Applicant	Delphos Implants - Ind.Com. Importacao E Exportacao DE
Product code	JEY
Device class	Class II
Decision date	Mar 29, 2019
Decision	Substantially Equivalent
Regulation	872.4760

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Source

View the full FDA submission: accessdata.fda.gov

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Delphos Implants Rigid Fixation System

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