Clearance Summary
Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System received FDA 510(k) clearance under submission number K170643, sponsored by Rti Surgical, Inc. Dba Rti Biologics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-04-14.
- Submission: K170643
- Applicant / Sponsor: Rti Surgical, Inc. Dba Rti Biologics
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2017-04-14
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.