Home / 510(k) Clearances / K090099

510(k) K090099

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

K090099 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 June 19, 2009. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), 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
June 19, 2009
Date Received
January 15, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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)
  • K101083 — DSS STABILIZATION SYSTEM (July 2, 2010)
  • K091944 — MODIFICATION TO: DSS STABILIZATION SYSTEM (August 3, 2009)

Other clearances for product code NKB

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources