Stronghold® T 3D Titanium Interbody Device System SW19106-3010

GUDID 10840642162059

Curved Titanium Cage - Lordotic 30 mm x 10 mm

Spine Wave, Inc.

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• Primary Device ID: 10840642162059
• NIH Device Record Key: b804af5b-df72-4d74-a878-a1dd0a44d6ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stronghold® T 3D Titanium Interbody Device System
• Version Model Number: SW19106-3010
• Catalog Number: SW19106-3010
• 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
• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Dimensions

• Length: 30 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Length: 30 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Length: 30 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Length: 30 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Length: 30 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Length: 30 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Length: 30 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree
• Length: 30 Millimeter
• Height: 10 Millimeter
• Angle: 6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642162059 [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: 2021-08-05
• Device Publish Date: 2021-07-28

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

• 10840642162110: Curved Titanium Cage - Lordotic 30 mm x 16 mm
• 10840642162103: Curved Titanium Cage - Lordotic 30 mm x 15 mm
• 10840642162097: Curved Titanium Cage - Lordotic 30 mm x 14 mm
• 10840642162080: Curved Titanium Cage - Lordotic 30 mm x 13 mm
• 10840642162073: Curved Titanium Cage - Lordotic 30 mm x 12 mm
• 10840642162066: Curved Titanium Cage - Lordotic 30 mm x 11 mm
• 10840642162059: Curved Titanium Cage - Lordotic 30 mm x 10 mm
• 10840642162042: Curved Titanium Cage - Lordotic 30 mm x 9 mm
• 10840642162035: Curved Titanium Cage - Lordotic 30 mm x 8 mm