FDA 510(k)

IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)

K-Number: K253577 · 2025-12-19

ApplicantMedicrea International S.A.S. (Medtronic)

Decision Date2025-12-19

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) is a medical device manufactured by Medicrea International S.A.S. (Medtronic). It received FDA 510(k) clearance on 2025-12-19 under approval number K253577. 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 (A24000000 / IB3D Universal Implant Inserter)?

IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Medicrea International S.A.S. (Medtronic). The 510(k) number is K253577.

When was IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) approved by the FDA?

IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) received FDA 510(k) clearance on 2025-12-19, under approval number K253577.

What company makes IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)?

IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) is manufactured by Medicrea International S.A.S. (Medtronic).

What is the FDA product code for IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)?

The FDA product code for IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) is MAX.

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Related PubMed Literature

PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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

K241164IB3D PL Spinal System K251629UNiD Spine Analyzer K261289UNiD Spine Analyzer (SW3002)

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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.