Invictus

FDA UDI

Class I (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: Invictus FDA UDI
Generic Name: Spinal guidewire FDA UDI
Device Name: THREADED TIP STAINLESS STEEL GUIDEWIRE 18" FDA UDI
Model / Reference: 16101-18-3 FDA UDI
Description: THREADED TIP STAINLESS STEEL GUIDEWIRE 18" FDA UDI

Identifiers

Primary DI / UDI-DI: 00190376160689 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Spinal guidewire FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Spinal guidewire

Invictus by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal guidewire.

Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
Cortera — Xtant Medical Holdings, Inc. · Class I
Cortera — Xtant Medical Holdings, Inc. · Class I
RAVINE® Lateral Access System — K2M, INC. · Class I
NILE™ Spinal System — K2M, INC. · Class II
MEGA PLUS MIS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
DeGen Standard Instrumentation — Degen Medical · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, 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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Alphatec Spine, Inc.

Sources (1)

FDA UDI aa12f8e3-bb3b-4f6c-a09a-47e5baa657e5 34 fields · synced Jun 8, 2026