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510(k) K090203

5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS by Ebi, L.P. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2009
Date Received
January 27, 2009
Clearance Type
Special
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 Ebi, L.P.

  • K100438 — POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM (June 23, 2010)
  • K100220 — POLARIS SPINAL SYSTEM (May 17, 2010)
  • K093880 — PEANUT GROWTH CONTROL PLATING SYSTEM (April 16, 2010)
  • K092574 — ESL SPINAL SYSTEM (February 4, 2010)
  • K093057 — BIOMET VISION FOOTRING SYSTEM (December 1, 2009)
  • K092336 — C-THRU SPINAL SYSTEM (October 15, 2009)
  • K091381 — IBEX SPINAL SYSTEM (August 7, 2009)
  • K090523 — POLARIS SPINAL SYSTEM (July 1, 2009)
  • K082406 — EXPANDABLE PEEK-OPTIMA IMPLANT (January 14, 2009)
  • K082187 — BIOMET ANTERIOR LUMBAR PLATE (November 13, 2008)

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)