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510(k) K243259

MASADA Modular Spinal Fixation System by Astura Medical — Product Code NKB

K243259 is an FDA 510(k) premarket notification submitted by Astura Medical for the device "MASADA Modular Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on January 7, 2025. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Astura Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2025
Date Received
October 15, 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 Astura Medical

  • K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (January 22, 2026)
  • K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (October 21, 2025)
  • K240160 — EGPS Navigated Instruments (October 17, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231694 — MASADA Modular Spinal Fixation System (November 16, 2023)
  • K232211 — REUNION Sacroiliac Joint Fusion System (October 24, 2023)
  • K223335 — SIRION Lateral Lumbar Interbody System (May 9, 2023)
  • K222097 — OLYMPIC Deformity Band System (May 4, 2023)
  • K222554 — EL CAPITAN Anterior Lumbar Interbody Fusion (January 19, 2023)
  • K214047 — EL CAPITAN Anterior Lumbar Interbody Fusion System (March 30, 2022)

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