Skip to content

SafeOp 3 AIX12100

by Alphatec Spine, Inc.

SafeOp 3 AIX12100 is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K234092 on 19 Apr 2024 and listed in FDA GUDID since 12 Nov 2024 (UDI-DI 00190376537108), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K234092

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190376537108 UDI-DI Date12 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK234092 Date19 Apr 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K234092 decided 19 Apr 2024 Active
  • FDA GUDID UDI-DI 00190376537108 listed 12 Nov 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K234092
  2. Listed FDA GUDID 00190376537108

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  • Withdrawn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
Subdermal needle electrode
Model / reference
AIX12100
Primary DI / UDI-DI
00190376537108
510(k) Number
FDA product code
GXZ
GMDN term
Subdermal needle electrode
Device class
Class II
Regulation number
882.1350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Subdermal needle electrode

Cleared under the same submission (K234092)

and 8 more cleared under K234092

Similar devices in this category

Other devices filed under Subdermal needle electrode.

Other devices from Alphatec Spine, Inc.

See all devices from Alphatec Spine, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)