FDA 510(k)

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

K-Nummer: K253577 · 2025-12-19

AntragstellerMedicrea International S.A.S. (Medtronic)

Entscheidungsdatum2025-12-19

ProduktcodeMAX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Medicrea International S.A.S. (Medtronic) als Antragsteller

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

Verwandte Geräte (Code: MAX)

K261049SCALA® TLSpineart SA 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 SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.