Clearance Summary
EXPEDIUM SPINE SYSTEM received FDA 510(k) clearance under submission number K102249, sponsored by Depuy Spine, A Johnson & Johnson Company. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-12-16.
- Submission: K102249
- Applicant / Sponsor: Depuy Spine, A Johnson & Johnson Company
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2010-12-16
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.