Zyfix Spinal Facet Screw System

FDA UDI

Class U (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name: Zyfix Spinal Facet Screw System FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: LUER SHAFT ASSY, LONG FDA UDI
Model / Reference: T076-0065 FDA UDI
Description: LUER SHAFT ASSY, LONG FDA UDI

Identifiers

Primary DI / UDI-DI: M697T07600651 FDA UDI
FDA Product Code: MRW FDA UDI
GMDN Term: General-purpose syringe, single-use FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: General-purpose syringe, single-use

Zyfix Spinal Facet Screw System by Xtant Medical Holdings, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as General-purpose syringe, single-use.

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HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
SURGYCO — Surgyco LLC · Class I

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 U	Pending data

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Manufacturer

Manufacturer: Xtant Medical Holdings, Inc.

Sources (1)

FDA UDI 720ca8bb-fa80-4321-ac3f-bc16de86a101 34 fields · synced Jun 8, 2026