Name: Predicase
Price: 199 USD

K-number	K231873
Device name	DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional
Applicant	Depuy Ireland UC
Product code	MEH
Device class	Class II
Decision date	Jan 19, 2024
Decision	Substantially Equivalent
Regulation	888.3353

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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DePuy SUMMIT Porocoat Hip Prosthesis  MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis  MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis  MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis  MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis  MR Conditional

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DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional