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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 the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International S.A.S. (Medtronic). It received FDA 510(k) clearance on 2025-12-19 under 510(k) 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. The listed applicant is Medicrea International S.A.S. (Medtronic). The 510(k) number is K253577.

When did IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) receive FDA 510(k) clearance?

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

Who is the listed applicant for IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)?

The FDA 510(k) record lists Medicrea International S.A.S. (Medtronic) as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Medicrea International S.A.S. (Medtronic) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261289UNiD™ Spine Analyzer (SW3002)K251629UNiD™ Spine AnalyzerK241164IB3D™ PL Spinal System

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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.

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