K-number	K241077
Device name	DeGen Medical Patient Specific Implant (PSI) System
Applicant	Degen Medical
Product code	OVD
Device class	Class II
Decision date	Oct 29, 2024
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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DeGen Medical Patient Specific Implant (PSI) System

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