FDA.report

510(k) K251016

Device
MectaLIF 3D Metal
Applicant
Medacta International S.A.
510(k) number
K251016
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-17
Date received
2025-04-02
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
07630542742965MectaLIF 3DMedacta International SA2025-07-25
07630542731051MectaLIF 3DMedacta International SA2025-07-25
07630542742828MectaLIF 3DMedacta International SA2025-07-25
07630542742835MectaLIF 3DMedacta International SA2025-07-25
07630542742842MectaLIF 3DMedacta International SA2025-07-25
07630542742859MectaLIF 3DMedacta International SA2025-07-25
07630542742866MectaLIF 3DMedacta International SA2025-07-25
07630542742873MectaLIF 3DMedacta International SA2025-07-25
07630542742880MectaLIF 3DMedacta International SA2025-07-25
07630542742897MectaLIF 3DMedacta International SA2025-07-25
07630542742903MectaLIF 3DMedacta International SA2025-07-25
07630542742910MectaLIF 3DMedacta International SA2025-07-25
07630542742927MectaLIF 3DMedacta International SA2025-07-25
07630542742934MectaLIF 3DMedacta International SA2025-07-25
07630542742941MectaLIF 3DMedacta International SA2025-07-25
07630542742958MectaLIF 3DMedacta International SA2025-07-25
07630542743115MectaLIF 3DMedacta International SA2025-07-25
07630542742972MectaLIF 3DMedacta International SA2025-07-25
07630542742989MectaLIF 3DMedacta International SA2025-07-25
07630542742996MectaLIF 3DMedacta International SA2025-07-25
07630542743009MectaLIF 3DMedacta International SA2025-07-25
07630542743016MectaLIF 3DMedacta International SA2025-07-25
07630542743023MectaLIF 3DMedacta International SA2025-07-25
07630542743030MectaLIF 3DMedacta International SA2025-07-25
07630542743047MectaLIF 3DMedacta International SA2025-07-25
07630542743054MectaLIF 3DMedacta International SA2025-07-25
07630542743061MectaLIF 3DMedacta International SA2025-07-25
07630542743078MectaLIF 3DMedacta International SA2025-07-25
07630542743085MectaLIF 3DMedacta International SA2025-07-25
07630542743092MectaLIF 3DMedacta International SA2025-07-25

Other 510(k) Records For Product Code MAX

510(k)DeviceApplicantDecision date
K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.2026-05-15
K260837VersaLift Expandable SystemLife Spine, Inc.2026-05-12
K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating systemCarlsmed, Inc.2026-05-09
K261067BEE PLIF CageNGMedical GmbH2026-04-30
K254017SWINGO-3D Lumbar Cage SystemImplanet2026-02-26
K253583LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23
K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.2026-02-04
K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.2026-01-23
K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)2025-12-19
K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24
K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))Mobarn Medical Devices, LLC2025-09-18
K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.2025-09-04