Stronghold® 3D Titanium Interbody Device System SW19169-2514

GUDID 10840642161427

Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 14 mm

Spine Wave, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 10840642161427
• NIH Device Record Key: 3cb813d6-c7e9-4358-90cf-ed5cece58c10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stronghold® 3D Titanium Interbody Device System
• Version Model Number: SW19169-2514
• Catalog Number: SW19169-2514
• Company DUNS: 067789763
• Company Name: Spine Wave, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Dimensions

• Width: 9.5 Millimeter
• Length: 25 Millimeter
• Height: 14 Millimeter
• Angle: 6 degree
• Width: 9.5 Millimeter
• Length: 25 Millimeter
• Height: 14 Millimeter
• Angle: 6 degree
• Width: 9.5 Millimeter
• Length: 25 Millimeter
• Height: 14 Millimeter
• Angle: 6 degree
• Width: 9.5 Millimeter
• Length: 25 Millimeter
• Height: 14 Millimeter
• Angle: 6 degree
• Width: 9.5 Millimeter
• Length: 25 Millimeter
• Height: 14 Millimeter
• Angle: 6 degree
• Width: 9.5 Millimeter
• Length: 25 Millimeter
• Height: 14 Millimeter
• Angle: 6 degree
• Width: 9.5 Millimeter
• Length: 25 Millimeter
• Height: 14 Millimeter
• Angle: 6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642161427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180990

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [Stronghold® 3D Titanium Interbody Device System]

• 10840642161502: Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 14 mm
• 10840642161496: Lumbar Titanium Cage – Convex 9.5 mm x 30 mm x 13 mm
• 10840642161489: Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 12 mm
• 10840642161472: Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 11 mm
• 10840642161465: Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 10 mm
• 10840642161458: Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 9 mm
• 10840642161441: Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 8 mm
• 10840642161434: Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 7 mm
• 10840642161342: Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 14 mm
• 10840642161335: Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 13 mm
• 10840642161328: Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 12 mm
• 10840642161311: Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 11 mm
• 10840642161304: Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 10 mm
• 10840642161298: Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 9 mm
• 10840642161281: Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 8 mm
• 10840642161274: Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 7 mm
• 10840642161182: Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 14 mm
• 10840642161175: Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 13 mm
• 10840642161168: Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 12 mm
• 10840642161151: Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 11 mm
• 10840642161144: Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 10 mm
• 10840642161137: Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 9 mm
• 10840642161120: Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 8 mm
• 10840642161113: Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 7 mm
• 10840642161595: Lumbar Titanium Cage - Lordotic 15° 9.5 mm x 22 mm x 7 mm
• 10840642161588: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 14 mm
• 10840642161571: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 13 mm
• 10840642161564: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 12 mm
• 10840642161557: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 11 mm
• 10840642161540: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 10 mm
• 10840642161533: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 9 mm
• 10840642161526: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 8 mm
• 10840642161519: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 7 mm
• 10840642161427: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 14 mm
• 10840642161410: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 13 mm
• 10840642161403: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 12 mm
• 10840642161397: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 11 mm
• 10840642161380: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 10 mm
• 10840642161373: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 9 mm
• 10840642161366: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 8 mm
• 10840642161359: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 7 mm
• 10840642161267: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 14 mm
• 10840642161250: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 13 mm
• 10840642161243: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 12 mm
• 10840642161236: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 11 mm
• 10840642161229: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 10 mm
• 10840642161212: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 9 mm
• 10840642161205: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 8 mm
• 10840642161199: Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 7 mm
• 10840642161748: Lumbar Titanium Cage - Lordotic 15° 9.5 mm x 25 mm x 14 mm