Clearance Summary
DualX Lumbar Intervertebral Body Fusion Device received FDA 510(k) clearance under submission number K192434, sponsored by Amplify Surgical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-10-15.
- Submission: K192434
- Applicant / Sponsor: Amplify Surgical, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2019-10-15
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.