K253577

Substantially Equivalent

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

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

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.