Clearance Summary
FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments received FDA 510(k) clearance under submission number K243659, sponsored by SeaSpine Orthopedics Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-04-02.
- Submission: K243659
- Applicant / Sponsor: SeaSpine Orthopedics Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2025-04-02
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.