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510(k) K072426

ATLAS SPINE PEDICLE SCREW SYSTEM by Atlas Spine, LLC — Product Code NKB

K072426 is an FDA 510(k) premarket notification submitted by Atlas Spine, LLC for the device "ATLAS SPINE PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 2007. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Atlas Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2007
Date Received
August 29, 2007
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 Atlas Spine, LLC

  • K252822 — Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (July 15, 2026)
  • K252560 — Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (November 10, 2025)
  • K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System (August 15, 2025)
  • K243191 — Atlas Spine Lateral Expandable Interbody System (November 26, 2024)
  • K202302 — Atlas Spine Rebar (Ti) Spacer System (October 30, 2020)
  • K192570 — Atlas Spine Expandable Cervical Standalone Interbody System (February 28, 2020)
  • K182418 — V3 Segmental Plating System (November 29, 2018)
  • K180675 — Atlas Spine Expandable Cervical Interbody System (June 13, 2018)
  • K172334 — Ortus™ Expandable Lumbar Interbody Fusion System (October 25, 2017)
  • K162918 — Atlas Spine Expandable Interbody System (February 9, 2017)

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