510(k) K072969

DSS by Paradigm Spine, LLC — Product Code NQP

Clearance Details

Decision: SESU ()
Decision Date: January 24, 2008
Date Received: October 22, 2007
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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K120491 — DSS STABILIZATION SYSTEM-RIGID (May 9, 2012)
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K093438 — PARADIGM INTERSPINOUS FUSION PLATE (October 6, 2010)
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K091944 — MODIFICATION TO: DSS STABILIZATION SYSTEM (August 3, 2009)

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)
K101083 — DSS STABILIZATION SYSTEM (July 2, 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)