Clearance Summary
SmartBase for Arthrex Glenoid IRIS received FDA 510(k) clearance under submission number K153215, sponsored by Custom Orthopaedic Solutions, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-02-19.
- Submission: K153215
- Applicant / Sponsor: Custom Orthopaedic Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2016-02-19
Classification & Regulation
This clearance is catalogued under FDA product code KWS and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.