Skip to content

X-Guide Surgical Navigation System

by X-Nav Technologies, LLC 4 variants

510(k) K150222

X-Guide Surgical Navigation System is a medical device (FDA Class II; FDA product code PLV, Dental Stereotaxic Instrument) made by X-Nav Technologies, LLC, cleared under FDA 510(k) K150222 on 8 Oct 2015, active as of 10 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150222 Date8 Oct 2015ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1391-2016 FDA Class II initiated 23 Feb 2016

    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

Timeline

2 dated events

  1. Cleared FDA 510(k) K150222
  2. Recall initiated FDA recalls Z-1391-2016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PLV
Device class
Class II
Regulation
21 CFR Part 872.4120
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K150222

119 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K150222
UDI-DISize and differences
X-Guide P007461
X-Nav Technologies, LLC
P007461 / P00746100817421020315
Single use: yes
On the market
X-Guide P007463
X-Nav Technologies, LLC
P007463 / P00746300817421020353
Single use: yes
On the market
X-Guide P007640
X-Nav Technologies, LLC
P007640 / P00764000817421020148
Single use: no
On the market
X-Guide P007652
X-Nav Technologies, LLC
P007652 / P00765200817421020162
Single use: no
On the market
X-Guide P007737
X-Nav Technologies, LLC
P007737 / P00773700817421020414
Single use: yes
On the market
X-Guide P007738
X-Nav Technologies, LLC
P007738 / P00773800817421020438
Single use: yes
On the market
X-Guide P007747
X-Nav Technologies, LLC
P007747 / P00774700817421020186
Single use: no
On the market
X-Guide P007749
X-Nav Technologies, LLC
P007749 / P00774900817421020278
Single use: no
On the market
X-Guide P007842
X-Nav Technologies, LLC
P007842 / P00784200817421020223
Single use: no
On the market
X-Guide P008296
X-Nav Technologies, LLC
P00829600817421022012
Single use: no
On the market
X-Guide P008296
X-Nav Technologies, LLC
P008296 / P00829600817421020001
Single use: no
On the market
X-Guide P008526
X-Nav Technologies, LLC
P008526 / P00852600817421020018
Single use: no
On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421021909
Single use: no
On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421022067
Single use: no
On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421020964
Single use: no
On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421022609
Single use: no
On the market
X-Guide P008542
X-Nav Technologies, LLC
P00854200817421021893
Single use: no
On the market
X-Guide P008802
X-Nav Technologies, LLC
P008802 / P00880200817421020216
Single use: no
No longer on the market
X-Guide P008810
X-Nav Technologies, LLC
P008810 / P00881000817421020513
Single use: no
On the market
X-Guide P008819
X-Nav Technologies, LLC
P008819 / P00881900817421020261
Single use: no
On the market
X-Guide P008930
X-Nav Technologies, LLC
P008930 / P00893000817421020117
Single use: no
On the market
X-Guide P009154
X-Nav Technologies, LLC
P009154 / P00915400817421022500
Single use: no
On the market
X-Guide P009181
X-Nav Technologies, LLC
P009181 / P00918100817421020155
Single use: no
On the market
X-Guide P009587
X-Nav Technologies, LLC
P009587 / P00958700817421020575
Single use: no
On the market
X-Guide P010303
X-Nav Technologies, LLC
P010303 / P01030300817421021336
Single use: yes
On the market
X-Guide P010304
X-Nav Technologies, LLC
P010304 / P01030400817421021350
Single use: yes
On the market
X-Guide P010305
X-Nav Technologies, LLC
P010305 / P01030500817421021374
Single use: yes
On the market
X-Guide P010306
X-Nav Technologies, LLC
P010306 / P01030600817421021398
Single use: yes
On the market
X-Guide P010307
X-Nav Technologies, LLC
P010307 / P01030700817421021411
Single use: yes
On the market
X-Guide P010308
X-Nav Technologies, LLC
P010308 / P01030800817421021435
Single use: yes
On the market
X-Guide P010670
X-Nav Technologies, LLC
P01067000817421020988
Single use: no
On the market
X-GUIDE P010722
X-Nav Technologies, LLC
P01072200817421021541
Single use: no
On the market
X-GUIDE P010725
X-Nav Technologies, LLC
P01072500817421021565
Single use: no
On the market
X-GUIDE P010726
X-Nav Technologies, LLC
P01072600817421021572
Single use: no
On the market
X-Guide P010813
X-Nav Technologies, LLC
P01081300817421021053
Single use: no
On the market
X-Guide P010814
X-Nav Technologies, LLC
P01081400817421021060
Single use: no
On the market
X-Guide P010815
X-Nav Technologies, LLC
P01081500817421021077
Single use: no
On the market
X-Guide P010816
X-Nav Technologies, LLC
P01081600817421021084
Single use: no
On the market
X-Guide P010860
X-Nav Technologies, LLC
P01086000817421021206
Single use: no
On the market
X-Guide P010870
X-Nav Technologies, LLC
P01087000817421022616
Single use: no
On the market
X-Guide P010870
X-Nav Technologies, LLC
P01087000817421021220
Single use: no
No longer on the market
X-Guide P010874
X-Nav Technologies, LLC
P01087400817421022623
Single use: no
On the market
X-Guide P010875
X-Nav Technologies, LLC
P01087500817421021275
Single use: no
On the market
X-Guide P010876
X-Nav Technologies, LLC
P01087600817421021282
Single use: no
On the market
X-Guide P011265
X-Nav Technologies, LLC
P01126500817421023668
Single use: yes
On the market
X-Guide P011271
X-Nav Technologies, LLC
P01127100817421023705
Single use: yes
On the market
X-Guide P011272
X-Nav Technologies, LLC
P01127200817421023712
Single use: yes
On the market
X-Guide P011693
X-Nav Technologies, LLC
P01169300817421023729
Single use: yes
On the market
X-Guide P011697
X-Nav Technologies, LLC
P01169700817421023750
Single use: yes
On the market
X-Guide P012127
X-Nav Technologies, LLC
P01212700817421023774
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code PLV (Dental Stereotaxic Instrument).

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 →