K242084
- 510(k) number
- K242084
- Device name
- EMPHASYS Acetabular Shell with RapiTite HA
- Applicant
- Depuy Ireland UC IE
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2024-10-07
- Date received
- 2024-07-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K242084.pdf
Official FDA record: K242084
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.