Stronghold® 3D Titanium Interbody Device System

FDA UDI

Class II (US FDA UDI)

by Spine Wave, Inc.

Identity

Trade Name: Stronghold® 3D Titanium Interbody Device System FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Lumbar Titanium Cage - Lordotic 15° 9.5 mm x 22 mm x 11 mm FDA UDI
Model / Reference: SW19159-2211 FDA UDI
Description: Lumbar Titanium Cage - Lordotic 15° 9.5 mm x 22 mm x 11 mm FDA UDI

Identifiers

Catalog Number: SW19159-2211 FDA UDI
Primary DI / UDI-DI: 10840642161632 FDA UDI
510(k) Number: K180990 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 9.5 Millimeter FDA UDI
Length — 22 Millimeter FDA UDI
Height — 11 Millimeter FDA UDI
Angle — 15 degree FDA UDI

Category: Metallic spinal interbody fusion cage

Stronghold® 3D Titanium Interbody Device System by Spine Wave, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Metallic spinal interbody fusion cage.

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MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

Cleared under the same submission

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: Spine Wave, Inc.

Sources (1)

FDA UDI fc185af9-deb0-4478-a3da-770354ac0095 37 fields · synced May 31, 2026