Clearance Summary
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software received FDA 510(k) clearance under submission number K142520, sponsored by Smith & Nephew, 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 2014-11-20.
- Submission: K142520
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2014-11-20
Classification & Regulation
This clearance is catalogued under FDA product code KTT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.