Clearance Summary
ORTHOPLAN received FDA 510(k) clearance under submission number K974406, sponsored by Ortho-Graphics, 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 1998-02-18.
- Submission: K974406
- Applicant / Sponsor: Ortho-Graphics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4800
- Decision date: 1998-02-18
Classification & Regulation
This clearance is catalogued under FDA product code HWT and 21 CFR 888.4800, within the Orthopedic review panel as a Class I device.