Clearance Summary
CLEARED UNDER GRAFTON II EDBM received FDA 510(k) clearance under submission number K122513, sponsored by Medtronic Sofamor Danek, 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 2013-03-06.
- Submission: K122513
- Applicant / Sponsor: Medtronic Sofamor Danek, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2013-03-06
Classification & Regulation
This clearance is catalogued under FDA product code MBP and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.