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510(k) K191066

CD Horizon™ Astute™ Spinal System by Medtronic Sofamor Danek USA, Inc. — Product Code NQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2019
Date Received
April 22, 2019
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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  • K243007 — CD Horizon™ Spinal System (October 23, 2024)
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Other clearances for product code NQP

  • K203678 — CD HORIZON™ Spinal System (January 15, 2021)
  • K182928 — CD Horizon™ Spinal System (January 11, 2019)
  • 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)
  • K080963 — DSS STABILIZATION SYSTEM (May 2, 2008)