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510(k) K231694

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

K231694 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 November 16, 2023. 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
November 16, 2023
Date Received
June 9, 2023
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)
  • K243259 — MASADA Modular Spinal Fixation System (January 7, 2025)
  • K240160 — EGPS Navigated Instruments (October 17, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • 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

  • 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