MectaLIF 3D Metal
K-Number: K251016 · 2025-07-17
ApplicantMedacta International S.A.
Decision Date2025-07-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MectaLIF 3D Metal is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-07-17 under approval number K251016. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MectaLIF 3D Metal?
MectaLIF 3D Metal is a medical device that received FDA 510(k) clearance on 2025-07-17. It is manufactured by Medacta International S.A.. The 510(k) number is K251016.
When was MectaLIF 3D Metal approved by the FDA?
MectaLIF 3D Metal received FDA 510(k) clearance on 2025-07-17, under approval number K251016.
What company makes MectaLIF 3D Metal?
MectaLIF 3D Metal is manufactured by Medacta International S.A..
What is the FDA product code for MectaLIF 3D Metal?
The FDA product code for MectaLIF 3D Metal is MAX.
Other Devices by Medacta International S.A.
Related Devices (Code: MAX)
K163180Hubble IIOrbbo Surgical, LLC
K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc.
K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL
K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.
K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.