K253577
- 510(k) number
- K253577
- Device name
- IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
- Applicant
- Medicrea International S.A.S. (Medtronic) FR
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-12-19
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K253577.pdf
Official FDA record: K253577
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.