Clearance Summary
EPICAGE INTERBODY FUSION DEVICE received FDA 510(k) clearance under submission number K092901, sponsored by R Tree Innovations. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-04-28.
- Submission: K092901
- Applicant / Sponsor: R Tree Innovations
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2010-04-28
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.