Clearance Summary
Apex 3D Total Ankle Replacement System received FDA 510(k) clearance under submission number K210390, sponsored by Paragon 28, 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 2021-03-06.
- Submission: K210390
- Applicant / Sponsor: Paragon 28, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3110
- Decision date: 2021-03-06
Classification & Regulation
This clearance is catalogued under FDA product code HSN and 21 CFR 888.3110, within the Orthopedic review panel as a Class II device.