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X-Guide P012129

by X-Nav Technologies, LLC

X-Guide P012129 is a surgical planning/navigation-enhancement system (FDA Class II) made by X-Nav Technologies, LLC, cleared under FDA 510(k) K253954 on 28 Aug 2026 (2 earlier submissions) and listed in FDA GUDID since 14 Oct 2026 (UDI-DI 00817421023798), active as of 2 Nov 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 ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817421023798 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253954 Date28 Aug 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253954 decided 28 Aug 2026 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00817421023798 listed 14 Oct 2026 Listed

Recalls

1 recall · FDA

    • Terminated Z-1391-2016 FDA Class II initiated 23 Feb 2016 on shared 510(k) K150222

    The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K150222
  2. Recall initiated FDA recalls Z-1391-2016
  3. Cleared FDA 510(k) K200662
  4. Cleared FDA 510(k) K253954
  5. Listed FDA GUDID 00817421023798

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
X-Guide
Generic name
Surgical planning/navigation-enhancement system
Model / reference
P012129
Primary DI / UDI-DI
00817421023798
510(k) Number
FDA product code
DZL, QRY
GMDN term
Surgical planning/navigation-enhancement system
Device class
Class II
Regulation number
872.4880, 872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K150222)

and 8 more cleared under K150222

Cleared under the same submission (K200662)

and 8 more cleared under K200662

Similar devices

Other devices filed under FDA product code DZL (Screw, Fixation, Intraosseous).

Other devices from X-Nav Technologies, LLC

  • X-Guide P011265

    Class II

  • X-Guide P011266

    Class II

  • X-Guide P011268

    Class II

  • X-Guide P011271

    Class II

See all devices from X-Nav Technologies, LLC →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Serial number
Other properties (11, all answered No)