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Universal Neuro 2

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
UNIVERSAL NEURO 2 FDA UDI
Generic Name
Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name
NEURO SCREWS,CROSS-PIN,SELF-DRILLING FDA UDI
Model / Reference
21-15904 FDA UDI
Description
NEURO SCREWS,CROSS-PIN,SELF-DRILLING FDA UDI

Identifiers

Catalog Number
21-15904 FDA UDI
Primary DI / UDI-DI
04546540491374 FDA UDI
510(k) Number
K031659 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 4.0 Millimeter FDA UDI

Universal Neuro 2 by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K031659 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 55d44069-b4b6-40b8-8cdb-28becbdadf01 37 fields · synced Jun 1, 2026