Universal Mandible AXS

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name: Universal Mandible AXS FDA UDI
Generic Name: Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name: Locking screws, AXS, self-tapping FDA UDI
Model / Reference: 56-23516 FDA UDI
Description: Locking screws, AXS, self-tapping FDA UDI

Identifiers

Catalog Number: 56-23516 FDA UDI
Primary DI / UDI-DI: 37613327567695 FDA UDI
FDA Product Code: DZL FDA UDI
GMDN Term: Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 16.0 Millimeter FDA UDI

Category: Craniofacial bone screw, non-bioabsorbable

The Universal Mandible AXS device is a self-tapping, locking screw-based craniofacial bone fixation solution designed for stable and secure fracture stabilization in various surgical procedures. This innovative medical device combines the benefits of non-bioabsorbable materials with precise locking mechanisms to ensure accurate implantation and optimal healing outcomes.

Similar devices

Also classified as Craniofacial bone screw, non-bioabsorbable.

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LEVEL ONE CMF — KLS-Martin L.P. · Class II
MatrixMANDIBLE — Synthes · Class II
OsteoMed — Osteomed Corp. · Class II
LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Stryker Leibinger

Sources (1)

FDA UDI 12913095-e803-4307-a621-003463cbec10 35 fields · synced Jun 21, 2026