510(k) K061304
K061304 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek for the device "CD HORIZON SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 2006. The device falls under product code NQP (Posterior Metal/Polymer Spinal System, Fusion), a Class II device regulated under 21 CFR 888.3070. Medtronic Sofamor Danek has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2006
- Date Received
- May 10, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Posterior Metal/Polymer Spinal System, Fusion
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.