510(k) K101083

DSS STABILIZATION SYSTEM by Paradigm Spine, LLC — Product Code NQP

Clearance Details

Decision: SESU ()
Decision Date: July 2, 2010
Date Received: April 19, 2010
Clearance Type: Special
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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Other clearances for product code NQP

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K133164 — DYNESYS TOP-LOADING SPINAL SYSTEM (January 16, 2014)
K101704 — ZIMMER DTO PIN PRESS INSTRUMENT (August 18, 2010)
K092234 — DYNESYS TOP-LOADING SPINAL SYSTEM (October 1, 2009)
K091944 — MODIFICATION TO: DSS STABILIZATION SYSTEM (August 3, 2009)
K073439 — TRANSITION STABILIZATION SYSTEM (February 20, 2009)
K080241 — DDS STABILIZATION SYSTEM (November 28, 2008)
K080963 — DSS STABILIZATION SYSTEM (May 2, 2008)