K253328
- 510(k) number
- K253328
- Device name
- GMK 3D Metal Tibial Tray Extension
- Applicant
- Medacta International S.A. CH
- Product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constra
- Decision date
- 2026-02-26
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253328.pdf
Official FDA record: K253328
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.