Clearance Summary
Fixated Asfora BULLET CAGE® (FABC) received FDA 510(k) clearance under submission number K181591, sponsored by Medical Designs, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-09-26.
- Submission: K181591
- Applicant / Sponsor: Medical Designs, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2018-09-26
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.