K242375
- 510(k) number
- K242375
- Device name
- OR3O Dual Mobility System
- Applicant
- Smith & Nephew, Inc. TN · US
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2024-10-07
- Date received
- 2024-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242375.pdf
Official FDA record: K242375
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.