K240046
- 510(k) number
- K240046
- Device name
- Ethylene Oxide Sterilization Supplier Change for MPO Hips
- Applicant
- Microport Orthopedics TN · US
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2024-04-18
- Date received
- 2024-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 6.4 MB · U.S. public domain
Also available from FDA: K240046.pdf
Official FDA record: K240046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.