GMK 3D Metal Tibial Tray Extension— 510(k) K253328
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K253328 for GMK 3D Metal Tibial Tray Extension, Substantially Equivalent on 2026-02-26. Applicant: Medacta International S.A.. Device class: 2.
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code MBH
view all- K261462 — LANDMARK Total Knee System
- K253728 — EVOLUTION® AM BIOFOAM® Tibial System
- K251840 — Zimmer® Persona® Personalized Knee System
- K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
- K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
More clearances from Medacta International S.A.
view allAdverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.