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: Self-retaining surgical retractor, reusable FDA UDI
Device Name: Iliac Crest Retractor, Fortex FDA UDI
Model / Reference: X022-0169 FDA UDI
Description: Iliac Crest Retractor, Fortex FDA UDI

Identifiers

Primary DI / UDI-DI: M697X02201691 FDA UDI
FDA Product Code: MNH FDA UDI
MNI FDA UDI
GMDN Term: Self-retaining surgical retractor, 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: Self-retaining surgical retractor, 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 Self-retaining surgical retractor, reusable.

Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
Life Instruments — Life Instrument Corporation · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, Inc. · 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 48a3485e-5ffe-467b-8918-dacc72573920 34 fields · synced Jun 6, 2026