K260536
- 510(k) number
- K260536
- Device name
- Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
- Applicant
- Depuy Ireland UC IE
- Product code
- KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
- Decision date
- 2026-05-15
- Date received
- 2026-02-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260536.pdf
Official FDA record: K260536
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.