Neurology · 510(k) · 2026
SafeOp 3: Neural Informatix System
Alphatec Spine, Inc.. Cleared by FDA on 11 January 2026 under submission K252842, product code GWF (stimulator, electrical, evoked response). What FDA's record says, in FDA's words.
Device record · K252842
- Device. SafeOp 3: Neural Informatix SystemDEVICE
- Company. Alphatec Spine, Inc.COMPANY
- Decision. 11 January 2026, 510(k), substantially equivalent (traditional review); received 8 September 2025DECISION
- Panel. NeurologyPANEL
- Product code. GWF, Stimulator, Electrical, Evoked ResponseCODE
- Regulation. 21 CFR 882.1870, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K252842Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? SafeOp 3: Neural Informatix System Please provide your Indications for Use below. The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures. SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches. I Z Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) Please select the types of uses (select one or both, as applicable). Traditional 510(k) Premarket Notification SafeOp TM 3 System This 510(k) summary of safety and effectiveness is being submitted in accordance with the […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionstriage or notification
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 3,348 reports filed against devices carrying product code GWF. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · NIM 4.0 CONSOLE · Medtronic Xomed Inc. · report 1045254-2026-01333
29 September 2026 · Malfunction · NIM 4.0 CONSOLE · Medtronic Xomed Inc. · report 1045254-2026-01327
It was reported that intra-op, the NIM Vital was giving an audible alarm approximately every minute with no corresponding alarm message displayed on screen. All connections were confirmed correct. The stimulation delivery tone was absent, although visual stimulation feedback was displayed under the stimulation current and muscle twitch was observed. No passive EMG activity was detected with Event Capture turned off, and no nerve response was observed when stimulating the RLN. Changing patient […]
29 September 2026 · Malfunction · NIM 4.0 CONSOLE · Medtronic Xomed Inc. · report 1045254-2026-01329
It was reported that the system's PI box "intermittently functions." There is no patient involvement.
29 September 2026 · Malfunction · NIM 4.0 PATIENT INTERFACE · Medtronic Xomed Inc. · report 1045254-2026-01330
28 September 2026 · Malfunction · NIM 4.0 CONSOLE · Medtronic Xomed Inc. · report 1045254-2026-01317
It was reported that during surgery, the patient interfaces were unable to stimulate and after troubleshooting perform Issue persisted with both PI boxes and unable to replicate any issues with patient simulator. There was no patient injury.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code GWF, in Neurology, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.