510(k) clearance
Mpact 3D Metal Foam
- 510(k) number
- K253630
- Applicant
- Medacta International S.A.
- Decision date
- Aug 28, 2026
- Date received
- Nov 19, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LPH
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II
- Regulation
- 21 CFR 888.3358
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Castel San Pietro, CH