K251292
- 510(k) number
- K251292
- Device name
- RECLAIM Monobloc Revision Femoral Stem
- Applicant
- Depuy Ireland UC IE
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2025-05-23
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251292.pdf
Official FDA record: K251292
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.