MECTALIF ANTERIOR— 510(k) K124034

Name: FDA 510(k) clearance K124034
Creator: U.S. Food and Drug Administration
Published: 2013-05-17

Substantially Equivalent

Medacta International

FDA 510(k) clearance K124034 for MECTALIF ANTERIOR, Substantially Equivalent on 2013-05-17. Applicant: Medacta International. Device class: 2.

Clearance details

Applicant: Medacta International
Product code: Product code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2012-12-28
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

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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

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K160605 — MectaLIF Anterior Stand-Alone2016-07-21
K160289 — MasterLoc Stem2016-05-20
K153664 — M.U.S.T. Pedicle Screw System2016-01-19
K151531 — MasterLoc Stem2015-10-30
K142744 — Mecta-C TiPEEK2015-05-07

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.