510(k) K133164

DYNESYS TOP-LOADING SPINAL SYSTEM by Zimmer Spine, Inc. — Product Code NQP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 16, 2014
Date Received: October 17, 2013
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.

Other clearances by Zimmer Spine, Inc.

K153631 — Zimmer Virage OCT Spinal Fixation System (February 16, 2016)
K150896 — Vitality Spinal Fixation System (August 31, 2015)
K151031 — Virage OCT Spinal Fixation System (June 24, 2015)
K142752 — Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation Syst (June 18, 2015)
K143626 — inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plati (March 20, 2015)
K143297 — Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Int (February 12, 2015)
K142053 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (October 29, 2014)
K141500 — OPTIO-C ANTERIOR CERVICAL SYSTEM (September 23, 2014)
K133556 — VIRAGE OCT SPINAL FIXATION SYSTEM (June 2, 2014)
K140611 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM (May 21, 2014)

Other clearances for product code NQP

K203678 — CD HORIZON Spinal System (January 15, 2021)
K191066 — CD Horizon Astute Spinal System (October 3, 2019)
K182928 — CD Horizon Spinal System (January 11, 2019)
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)