MectaLIF Anterior Lag Extension— 510(k) K232123

Name: FDA 510(k) clearance K232123
Creator: U.S. Food and Drug Administration
Published: 2023-10-18

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K232123 for MectaLIF Anterior Lag Extension, Substantially Equivalent on 2023-10-18. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-07-17
Decision date: 2023-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

view all

K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10
K254202 — MectaLIF 3D Metal Anterior2026-05-05

More clearances from Medacta International S.A.

view all

K253630 — Mpact 3D Metal Foam2026-08-28
K253940 — M.U.S.T. Pedicle Screw System - Extension2026-04-28
K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26
K250644 — MSS - Monobloc stem2026-02-03
K251043 — Mpact 3D Metal Implants Extension DMLS Technology2026-01-28

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.