Clearance Summary
DYNESYS SPINAL SYSTEM received FDA 510(k) clearance under submission number K031511, sponsored by Centerpulse Spine-Tech, 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 2004-03-05.
- Submission: K031511
- Applicant / Sponsor: Centerpulse Spine-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2004-03-05
Classification & Regulation
This clearance is catalogued under FDA product code NQP and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.