Clearance Summary
PathLoc-SI Joint Fusion System received FDA 510(k) clearance under submission number K153656, sponsored by L&K BIOMED 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 2016-11-14.
- Submission: K153656
- Applicant / Sponsor: L&K BIOMED Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2016-11-14
Classification & Regulation
This clearance is catalogued under FDA product code OUR and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.