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Universal Neuro 3

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
UNIVERSAL NEURO 3 FDA UDI
Generic Name
Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name
Screw, self-drilling FDA UDI
Model / Reference
56-15945 FDA UDI
Description
Screw, self-drilling FDA UDI

Identifiers

Catalog Number
56-15945 FDA UDI
Primary DI / UDI-DI
37613327004046 FDA UDI
510(k) Number
K112557 FDA UDI
FDA Product Code
HBW FDA UDI
GMDN Term
Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5360 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 5.0 Millimeter FDA UDI

Universal Neuro 3 by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K112557 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 1165642c-3da4-4c05-b4a1-d19e08d9a838 37 fields · synced Jun 6, 2026