FDA 510(k)

IB3D PL Spinal System

K-Number: K241164 · 2024-09-06

ApplicantMedicrea International S.A.S. (Medtronic)

Decision Date2024-09-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

IB3D PL Spinal System is a medical device manufactured by Medicrea International S.A.S. (Medtronic). It received FDA 510(k) clearance on 2024-09-06 under approval number K241164. 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 IB3D PL Spinal System?

IB3D PL Spinal System is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Medicrea International S.A.S. (Medtronic). The 510(k) number is K241164.

When was IB3D PL Spinal System approved by the FDA?

IB3D PL Spinal System received FDA 510(k) clearance on 2024-09-06, under approval number K241164.

What company makes IB3D PL Spinal System?

IB3D PL Spinal System is manufactured by Medicrea International S.A.S. (Medtronic).

What is the FDA product code for IB3D PL Spinal System?

The FDA product code for IB3D PL Spinal System is MAX.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Medicrea International S.A.S. (Medtronic)

K253577IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) K251629UNiD Spine Analyzer K261289UNiD Spine Analyzer (SW3002)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.