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510(k) K242069

Eminent Spine Scoliosis Deformity Pedicle Screw System by Eminent Spine — Product Code NKB

K242069 is an FDA 510(k) premarket notification submitted by Eminent Spine for the device "Eminent Spine Scoliosis Deformity Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on September 3, 2024. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Eminent Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2024
Date Received
July 15, 2024
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 Eminent Spine

  • K250894 — Eminent Spine Posterior SI System (October 7, 2025)
  • K241663 — Eminent Spine 3D Titanium Pedicle Screw System (April 28, 2025)
  • K240505 — Eminent Spine SI Screw System (June 4, 2024)
  • K230219 — Eminent Spine 3D Lumbar Interbody Fusion Systems (May 16, 2023)
  • K212701 — Eminent Spine 3D Cervical Interbody Fusion System (February 6, 2023)
  • K221936 — Standalone ALIF Interbody Fusion System (October 17, 2022)
  • K212853 — Cervical Stand-Alone System (November 5, 2021)
  • K201979 — Cervical Plate System (August 25, 2020)
  • K143365 — Eminent Foot Plate System (March 30, 2015)
  • K133194 — DIAMOND RATTLESNAKE SYSTEM (June 26, 2014)

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