Clearance Summary
IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) received FDA 510(k) clearance under submission number K253577, sponsored by Medicrea International S.A.S. (Medtronic). The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-12-19.
- Submission: K253577
- Applicant / Sponsor: Medicrea International S.A.S. (Medtronic)
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2025-12-19
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.