Fortex Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name: Fortex Pedicle Screw System FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Cross Connector, Locking Driver FDA UDI
Model / Reference: X070-0040 FDA UDI
Description: Cross Connector, Locking Driver FDA UDI

Identifiers

Primary DI / UDI-DI: M697X07000401 FDA UDI
FDA Product Code: MNH FDA UDI
MNI FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 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: Surgical screwdriver, reusable

Fortex Pedicle Screw System by Xtant Medical Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical screwdriver, reusable.

MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
PERLA ® TL — Spineart · Class II
USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
KLOCKNER — SOADCO, S.L. · 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 II	Pending data

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Manufacturer

Manufacturer: Xtant Medical Holdings, Inc.

Sources (1)

FDA UDI be91de04-2b0e-4c74-a4fd-d496bb378007 34 fields · synced May 29, 2026