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SafeOp 3 AIX11240

by Alphatec Spine, Inc.

SafeOp 3 AIX11240 is a neurophysiologic monitoring system (FDA Class II) made by Alphatec Spine, Inc., cleared under FDA 510(k) K252842 on 11 Jan 2026 (1 earlier submission) and listed in FDA GUDID since 12 Nov 2024 (UDI-DI 00190376517506), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252842 Date11 Jan 2026DecidedStatusActive
United StatesGUDID listing Number00190376517506 UDI-DI Date12 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252842 decided 11 Jan 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00190376517506 listed 12 Nov 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2793-2026 FDA Class II initiated 13 May 2026

    Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.

Timeline

4 dated events

  1. Cleared FDA 510(k) K234092
  2. Listed FDA GUDID 00190376517506
  3. Cleared FDA 510(k) K252842
  4. Recall initiated FDA recalls Z-2793-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SafeOp 3
Generic name
Neurophysiologic monitoring system
Model / reference
AIX11240
Primary DI / UDI-DI
00190376517506
510(k) Number
FDA product code
GWF, PDQ, GXZ, GXY, IKN, ETN
GMDN term
Neurophysiologic monitoring system
Device class
Class II
Regulation number
882.1870, 874.1820, 882.1350, 882.1320, 890.1375
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Neurophysiologic monitoring system

Cleared under the same submission (K234092)

and 8 more cleared under K234092

Cleared under the same submission (K252842)

Similar devices in this category

Other devices filed under Neurophysiologic monitoring system.

Other devices from Alphatec Spine, Inc.

See all devices from Alphatec Spine, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)