Clearance Summary
HC Spinal System received FDA 510(k) clearance under submission number K151362, sponsored by Hung Chun Bio-S Co., 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 2016-05-05.
- Submission: K151362
- Applicant / Sponsor: Hung Chun Bio-S Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2016-05-05
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.