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510(k) K062685

EBI ARAY SPINAL SYSTEM by Ebi, L.P. — Product Code NKB

K062685 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "EBI ARAY SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 2006. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Ebi, L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2006
Date Received
September 8, 2006
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)
  • K090203 — 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS (July 30, 2009)
  • K090523 — POLARIS SPINAL SYSTEM (July 1, 2009)
  • K082406 — EXPANDABLE PEEK-OPTIMA IMPLANT (January 14, 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