Clearance Summary
DISTAL RADIO-ULNAR JOINT IMPLANT received FDA 510(k) clearance under submission number K053119, sponsored by Aptis Medical, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-12-07.
- Submission: K053119
- Applicant / Sponsor: Aptis Medical, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3810
- Decision date: 2005-12-07
Classification & Regulation
This clearance is catalogued under FDA product code KXE and 21 CFR 888.3810, within the Orthopedic review panel as a Class II device.