FDA.reportPublic FDA data

510(k) K254202

Device
MectaLIF 3D Metal Anterior
Applicant
Medacta International S.A.
510(k) number
K254202
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-05
Date received
2025-12-29
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Stefano Baj
Address
Strada Regina Castel San Pietro CH 6874 6874

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVD#

510(k), Device, Applicant table
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K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2024-12-13
K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc.2024-11-26
K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical2024-10-29