510(k) clearance
M-Vizion Femoral Revision System Extension
- 510(k) number
- K260173
- Applicant
- Medacta International S.A.
- Decision date
- Sep 17, 2026
- Date received
- Jan 21, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LZO
- Device type
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class II
- Regulation
- 21 CFR 888.3353
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Castel San Pietro, CH