MectaLIF 3D Metal Anterior— 510(k) K254202
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K254202 for MectaLIF 3D Metal Anterior, Substantially Equivalent on 2026-05-05. Applicant: Medacta International S.A.. Device class: 2.
Summary
Medacta International's MectaLIF 3D Metal Anterior is filed under OVD, lumbar intervertebral fusion devices with integrated fixation.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).
Medacta filed from Castel San Pietro, Switzerland. The decision came 127 calendar days after receipt (December 29, 2025 to May 5, 2026).
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Product code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code OVD
view allMore clearances from Medacta International S.A.
view allAdverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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.