Clearance Summary
4CIS SARA Spine System, 4CIS VERTU Spine System received FDA 510(k) clearance under submission number K202498, sponsored by Solco Biomedical Company India Private Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-02-18.
- Submission: K202498
- Applicant / Sponsor: Solco Biomedical Company India Private Limited
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2021-02-18
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.