K241164
- 510(k) number
- K241164
- Device name
- IB3D PL Spinal System
- Applicant
- Medicrea International S.A.S. (Medtronic) FR
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-06
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K241164.pdf
Official FDA record: K241164
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.