Clearance Summary
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM received FDA 510(k) clearance under submission number K102458, sponsored by Solco Biomedical Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-06-13.
- Submission: K102458
- Applicant / Sponsor: Solco Biomedical Co., Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2011-06-13
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.