SafeOp 3: Neural Informatix Systeem
FDA 510(k) K234092 · Alphatec Spine, Inc.
510(k) numberK234092
Submission
- Device name
- SafeOp 3: Neural Informatix Systeem
- Applicant
- Alphatec Spine, Inc.
Carlsbad, CA, US - Received
- December 26, 2023
- Decision date
- April 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GWF
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|---|---|---|---|
| K253301 | BraiN20® (BraiN20)GWF · Traditional | Time IS Brain, S.L. | 06/27/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 01/11/2026SE |
| K243982 | Nicolet EDXGWF · Special | Natus Neurology Incorporated | 01/22/2025SE |
| K243495 | Natus Ultrapro S100 (982A0594)GWF · Special | Natus Neurology Incorporated | 12/12/2024SE |
| K242345 | Delphi StimulatorGWF · Traditional | Quantalx Neuroscience | 11/05/2024SE |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional | Soterix Medical, Inc. | 03/25/2024SE |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special | Inomed Medizintechnik GmbH | 10/27/2023SE |
| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 03/09/2022SE |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Traditional | Inomed Medizintechnik GmbH | 01/07/2022SE |
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| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…OLO · Traditional | 02/19/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | 01/11/2026SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | 09/03/2025SE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | 08/28/2025SE |
| K251080 | IdentiTi II Cervical Interbody SystemODP · Traditional | 07/03/2025SE |
| K243461 | Calibrate Interbody Systems · Traditional | 03/04/2025SE |
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Questions and answers
When was SafeOp 3: Neural Informatix Systeem cleared by the FDA?
SafeOp 3: Neural Informatix Systeem (K234092) received a 510(k) decision of Substantially Equivalent on April 19, 2024, 115 days after the submission was received.
What is the product code of K234092?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.