Clearance Summary
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal received FDA 510(k) clearance under submission number K162697, 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 2017-02-10.
- Submission: K162697
- Applicant / Sponsor: Custom Orthopaedic Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2017-02-10
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.