Clearance Summary
GROWTH GUIDANCE PLATE received FDA 510(k) clearance under submission number K031493, sponsored by University of Utah/School of Medicine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-11-20.
- Submission: K031493
- Applicant / Sponsor: University of Utah/School of Medicine
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2003-11-20
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.