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510(k) K101083

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

K101083 is an FDA 510(k) premarket notification submitted by Paradigm Spine, LLC for the device "DSS STABILIZATION SYSTEM". The FDA issued a decision of SESU on July 2, 2010. The device falls under product code NQP (Posterior Metal/Polymer Spinal System, Fusion), a Class II device regulated under 21 CFR 888.3070. Paradigm Spine, LLC has at least 10 other 510(k) clearances on record.

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.

Other clearances by Paradigm Spine, LLC

  • K213493 — Fortilink with TiPlus Technology (January 27, 2022)
  • K201453 — Fortilink Cages with TiPlus Technology (October 7, 2020)
  • K201704 — CoFix System (August 4, 2020)
  • K153302 — coflex-IF (September 8, 2016)
  • K120491 — DSS STABILIZATION SYSTEM-RIGID (May 9, 2012)
  • K112595 — COFLEX-F (February 13, 2012)
  • K113625 — DSS STABILIZATION SYSTEM (January 10, 2012)
  • K093438 — PARADIGM INTERSPINOUS FUSION PLATE (October 6, 2010)
  • K091944 — MODIFICATION TO: DSS STABILIZATION SYSTEM (August 3, 2009)
  • K090099 — DSS STABILIZATION SYSTEM (June 19, 2009)

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)
  • 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)

FDA data resources