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X-Guide P012184

by X-Nav Technologies, LLC

X-Guide P012184 is a surgical planning/navigation-enhancement system (FDA Class II) made by X-Nav Technologies, LLC, listed in FDA GUDID since 13 Oct 2026 (UDI-DI 00817421023613), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817421023613 UDI-DI Date13 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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
P012184
Primary DI / UDI-DI
00817421023613
FDA product code
PLV, QRY
GMDN term
Surgical planning/navigation-enhancement system
Device class
Class II
Regulation number
872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code QRY.

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