IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)— 510(k) K253577

Name: FDA 510(k) clearance K253577
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Substantially Equivalent

Medicrea International S.A.S. (Medtronic)

FDA 510(k) clearance K253577 for IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter), Substantially Equivalent on 2025-12-19. Applicant: Medicrea International S.A.S. (Medtronic). Device class: 2.

Clearance details

Applicant: Medicrea International S.A.S. (Medtronic)
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-11-17
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Rillieux-La-Pape, FR

Download summary PDF View on FDA.gov ↗

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K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
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K261289 — UNiD Spine Analyzer (SW3002)2026-05-15
K251629 — UNiD Spine Analyzer2025-08-07
K241164 — IB3D PL Spinal System2024-09-06

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.