K242232
- 510(k) number
- K242232
- Device name
- Mpact 3D Metal Augments II
- Applicant
- Medacta International S.A. CH
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2025-04-23
- Date received
- 2024-07-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K242232.pdf
Official FDA record: K242232
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.