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: Bone tap, reusable FDA UDI
Device Name: 6.5mm Aggressive Tap, Fortex/X90 FDA UDI
Model / Reference: X010-0602 FDA UDI
Description: 6.5mm Aggressive Tap, Fortex/X90 FDA UDI

Identifiers

Primary DI / UDI-DI: M697X01006021 FDA UDI
FDA Product Code: MNI FDA UDI
MNH FDA UDI
GMDN Term: Bone tap, 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: Bone tap, reusable

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

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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 659e12df-4c23-4bab-80a7-350890ad398e 34 fields · synced May 30, 2026