K251043
- 510(k) number
- K251043
- Device name
- Mpact 3D Metal Implants Extension DMLS Technology
- Applicant
- Medacta International S.A. CH
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2026-01-28
- Date received
- 2025-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K251043.pdf
Official FDA record: K251043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.