Clearance Summary
SPICCA Stand-Alone Cervical Fusion Cages received FDA 510(k) clearance under submission number K230608, sponsored by Southern Medical (Pty) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-08-14.
- Submission: K230608
- Applicant / Sponsor: Southern Medical (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2023-08-14
Classification & Regulation
This clearance is catalogued under FDA product code OVE and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.