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X-Guide P010305

by X-Nav Technologies, LLC

X-Guide P010305 is a Class II device made by X-Nav Technologies, LLC, cleared under FDA 510(k) K200662 on 21 May 2020 (1 earlier submission) and listed in FDA GUDID since 25 Jan 2021 (UDI-DI 00817421021374), active as of 22 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 ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817421021374 UDI-DI Date25 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK200662 Date21 May 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200662 decided 21 May 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00817421021374 listed 25 Jan 2021 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

4 dated events

  1. Cleared FDA 510(k) K150222
  2. Recall initiated FDA recalls Z-1391-2016
  3. Cleared FDA 510(k) K200662
  4. Listed FDA GUDID 00817421021374

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  • Withdrawn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 / Ref / Catalog
P010305
Primary DI / UDI-DI
00817421021374
510(k) Number
FDA product code
QRY, DZL
GMDN term
Surgical planning/navigation-enhancement system
Device class
Class II
Regulation number
872.4120, 872.4880
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Craniofacial bone screw, non-bioabsorbableSurgical planning/navigation-enhancement system

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 in this category

Other devices filed under Surgical planning/navigation-enhancement system.

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)