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510(k) K213849

SafeOp 2: Neural Informatix System by Alphatec Spine, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2022
Date Received
December 10, 2021
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

Other clearances by Alphatec Spine, Inc.

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Other clearances for product code GWF

  • K252842 — SafeOp 3: Neural Informatix System (January 11, 2026)
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  • 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)
  • K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)
  • K192823 — MEGA-TMS (August 13, 2021)