← Back to catalogue

X-Guide

FDA UDI

Class II (US FDA UDI)

by X-Nav Technologies, LLC

Identity

Trade Name
X-GUIDE FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Device Name
ADAPTOR SLEEVE - 5 FDA UDI
Model / Reference
P010720 FDA UDI
Description
ADAPTOR SLEEVE - 5 FDA UDI

Identifiers

Primary DI / UDI-DI
00817421021527 FDA UDI
510(k) Number
K150222 FDA UDI
K192579 FDA UDI
FDA Product Code
PLV FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical planning/navigation-enhancement system

X-Guide by X-Nav Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical planning/navigation-enhancement system.

Cleared under the same submission

K150222 also covers:

K192579 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
X-Nav Technologies, LLC

Sources (1)

  • FDA UDI 6eb3b053-6685-44a3-b9d1-7bf6de6d4e36 34 fields · synced May 31, 2026