Clearance Summary
FlareHawk Interbody Fusion System received FDA 510(k) clearance under submission number K243116, sponsored by Integrity Implants Inc. Dba Accelus. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-05-21.
- Submission: K243116
- Applicant / Sponsor: Integrity Implants Inc. Dba Accelus
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2025-05-21
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.