Stronghold® C 3D Titanium Interbody Device System SW18125-1408

GUDID 10840642162004

Cervical Titanium Cage - Anatomical 17.5 mm x 14 mm x 8 mm

Spine Wave, Inc.

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• Primary Device ID: 10840642162004
• NIH Device Record Key: afca6cc9-21f7-44a1-942b-8bcb9c436ea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stronghold® C 3D Titanium Interbody Device System
• Version Model Number: SW18125-1408
• Catalog Number: SW18125-1408
• 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: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com

Device Dimensions

• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter
• Width: 17.5 Millimeter
• Length: 14 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642162004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181229

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

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: 2021-12-14
• Device Publish Date: 2021-12-06

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

• 10840642162028: Cervical Titanium Cage - Anatomical 17.5 mm x 14 mm x 10 mm
• 10840642162011: Cervical Titanium Cage - Anatomical 17.5 mm x 14 mm x 9 mm
• 10840642162004: Cervical Titanium Cage - Anatomical 17.5 mm x 14 mm x 8 mm
• 10840642161991: Cervical Titanium Cage - Anatomical 17.5 mm x 14 mm x 7 mm
• 10840642161984: Cervical Titanium Cage - Anatomical 17.5 mm x 14 mm x 6 mm
• 10840642161977: Cervical Titanium Cage - Anatomical 17.5 mm x 14 mm x 5 mm
• 10840642161960: Cervical Titanium Cage - Anatomical 15 mm x 12 mm x 10 mm
• 10840642161953: Cervical Titanium Cage - Anatomical 15 mm x 12 mm x 9 mm
• 10840642161946: Cervical Titanium Cage - Anatomical 15 mm x 12 mm x 8 mm
• 10840642161939: Cervical Titanium Cage - Anatomical 15 mm x 12 mm x 7 mm
• 10840642161922: Cervical Titanium Cage - Anatomical 15 mm x 12 mm x 6 mm
• 10840642161915: Cervical Titanium Cage - Anatomical 15 mm x 12 mm x 5 mm
• 10840642161908: Cervical Titanium Cage - Lordotic 17.5 mm x 14 mm x 12 mm
• 10840642161892: Cervical Titanium Cage - Lordotic 17.5 mm x 14 mm x 11 mm
• 10840642161885: Cervical Titanium Cage - Lordotic 17.5 mm x 14 mm x 10 mm
• 10840642161878: Cervical Titanium Cage - Lordotic 17.5 mm x 14 mm x 9 mm
• 10840642161861: Cervical Titanium Cage - Lordotic 17.5 mm x 14 mm x 8 mm
• 10840642161854: Cervical Titanium Cage - Lordotic 17.5 mm x 14 mm x 7 mm
• 10840642161847: Cervical Titanium Cage - Lordotic 17.5 mm x 14 mm x 6 mm
• 10840642161830: Cervical Titanium Cage - Lordotic 17.5 mm x 14 mm x 5 mm
• 10840642161823: Cervical Titanium Cage - Lordotic 15 mm x 12 mm x 12 mm
• 10840642161816: Cervical Titanium Cage - Lordotic 15 mm x 12 mm x 11 mm
• 10840642161809: Cervical Titanium Cage - Lordotic 15 mm x 12 mm x 10 mm
• 10840642161793: Cervical Titanium Cage - Lordotic 15 mm x 12 mm x 9 mm
• 10840642161786: Cervical Titanium Cage - Lordotic 15 mm x 12 mm x 8 mm
• 10840642161779: Cervical Titanium Cage - Lordotic 15 mm x 12 mm x 7 mm
• 10840642161762: Cervical Titanium Cage - Lordotic 15 mm x 12 mm x 6 mm
• 10840642161755: Cervical Titanium Cage - Lordotic 15 mm x 12 mm x 5 mm