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510(k) K252842

SafeOp 3: Neural Informatix System by Alphatec Spine, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2026
Date Received
September 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

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Other clearances for product code GWF

  • K243982 — Nicolet EDX (January 22, 2025)
  • K243495 — Natus Ultrapro S100 (982A0594) (December 12, 2024)
  • K242345 — Delphi Stimulator (November 5, 2024)
  • K234092 — SafeOp 3: Neural Informatix Systeem (April 19, 2024)
  • K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (March 25, 2024)
  • K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (October 27, 2023)
  • K230415 — Cadwell Guardian (August 17, 2023)
  • K213849 — SafeOp 2: Neural Informatix System (March 9, 2022)
  • K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)
  • K192823 — MEGA-TMS (August 13, 2021)