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510(k) K090099

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

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

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  • 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

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)