510(k) K061304

CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek — Product Code NQP

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.

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