K231873
- 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.