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510(k) K241663

Eminent Spine 3D Titanium Pedicle Screw System by Eminent Spine — Product Code NKB

K241663 is an FDA 510(k) premarket notification submitted by Eminent Spine for the device "Eminent Spine 3D Titanium Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on April 28, 2025. 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
April 28, 2025
Date Received
June 7, 2024
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 Eminent Spine

  • K250894 — Eminent Spine Posterior SI System (October 7, 2025)
  • K242069 — Eminent Spine Scoliosis Deformity Pedicle Screw System (September 3, 2024)
  • 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

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • 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)

FDA data resources