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510(k) K231799

INERTIA® CONNEXX™ Modular Pedicle Screw System by Nexxt Spine, LLC — Product Code NKB

K231799 is an FDA 510(k) premarket notification submitted by Nexxt Spine, LLC for the device "INERTIA® CONNEXX™ Modular Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on July 20, 2023. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Nexxt Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2023
Date Received
June 20, 2023
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 Nexxt Spine, LLC

  • K243838 — NEXXT MATRIXX® SI System (March 14, 2025)
  • K240690 — STRUXXURE® MCS Anterior Cervical Plate System (March 22, 2024)
  • K221905 — INERTIA CONNEXX Modular Pedicle Screw System (July 28, 2022)
  • K220291 — NEXXT SPINE NAVIGATION System (March 31, 2022)
  • K202230 — NEXXT MATRIXX Stand Alone ALIF System (December 15, 2020)
  • K202192 — STRUXXURE®-L and STRUXXURE®-A Plate System (September 17, 2020)
  • K200969 — NEXXT MATRIXX System (May 21, 2020)
  • K200543 — NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (March 23, 2020)
  • K193412 — NEXXT MATRIXX System (February 24, 2020)
  • K193370 — Nexxt Matrixx System (January 21, 2020)

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