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510(k) K120491

DSS STABILIZATION SYSTEM-RIGID by Paradigm Spine, LLC — Product Code MNH

K120491 is an FDA 510(k) premarket notification submitted by Paradigm Spine, LLC for the device "DSS STABILIZATION SYSTEM-RIGID". The FDA issued a decision of SESU on May 9, 2012. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), 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
May 9, 2012
Date Received
February 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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)
  • 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)
  • K090099 — DSS STABILIZATION SYSTEM (June 19, 2009)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)

FDA data resources