K231873

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

510(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 IE
Product code
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal
Decision date
2024-01-19
Date received
2023-06-26
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 9.3 MB · U.S. public domain

Also available from FDA: K231873.pdf

Official FDA record: K231873
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.