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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
BONE SCREW, EDX - 2.7Ø x 4mm FDA UDI
Model / Reference
P010303 FDA UDI
Description
BONE SCREW, EDX - 2.7Ø x 4mm FDA UDI

Identifiers

Catalog Number
P010303 FDA UDI
Primary DI / UDI-DI
00817421021336 FDA UDI
510(k) Number
K150222 FDA UDI
K200662 FDA UDI
FDA Product Code
DZL FDA UDI
QRY FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4880 FDA UDI
872.4120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Craniofacial bone screw, non-bioabsorbableSurgical 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:

K200662 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
X-Nav Technologies, LLC

Sources (1)

  • FDA UDI 2946cb06-7263-4b0d-8f57-8da39c989f9b 35 fields · synced May 30, 2026