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X-Guide P012128

by X-Nav Technologies, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817421023781 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: in commercial distribution

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
X-Guide
Generic Name
Surgical planning/navigation-enhancement system
Model / Reference
P012128
Primary DI / UDI-DI
00817421023781
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
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K150222)

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Cleared under the same submission (K200662)

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Cleared under the same submission (K253954)

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Other devices from X-Nav Technologies, LLC

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Properties

  • Single Use
  • Prescription Use
  • Serial Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No