Clearance Summary
Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 received FDA 510(k) clearance under submission number K234051, sponsored by Spinal Simplicity, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-01-18.
- Submission: K234051
- Applicant / Sponsor: Spinal Simplicity, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 2024-01-18
Classification & Regulation
This clearance is catalogued under FDA product code PEK and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.