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510(k) K060638

DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS by Zimmer Spine, Inc. — Product Code NQP

K060638 is an FDA 510(k) premarket notification submitted by Zimmer Spine, Inc. for the device "DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS". The FDA issued a decision of Substantially Equivalent on April 6, 2006. The device falls under product code NQP (Posterior Metal/Polymer Spinal System, Fusion), a Class II device regulated under 21 CFR 888.3070. Zimmer Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2006
Date Received
March 10, 2006
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.

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)
  • 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)

FDA data resources