Velocity™ Expandable Interbody System 10-2250

GUDID 10840642107876

Velocity® Lateral Surgical Gun Assembly

Spine Wave, Inc.

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 10840642107876
• NIH Device Record Key: f708e2bb-b25e-4ade-af44-39f1d00adc87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velocity™ Expandable Interbody System
• Version Model Number: 10-2250
• Catalog Number: 10-2250
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642107876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152620

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[10840642107876]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-24

On-Brand Devices [Velocity™ Expandable Interbody System]

• 10840642107876: Velocity® Lateral Surgical Gun Assembly
• 10840642107869: Velocity® Posterior Surgical Gun Assembly
• 10840642106916: Expandable Implant, 25(L) X 10(W) X 8-14(H) 8 Degree Lordotic
• 10840642106909: Expandable Implant, 22(L) X 10(W) X 8-14(H) 8 Degree Lordotic
• 10840642106893: Expandable Implant, 25(L) X 10(W) X 8-14(H), Biconvex
• 10840642106886: Expandable Implant, 22(L) X 10(W) X 8-14(H), Biconvex
• 10840642106879: Expandable Implant, 55(L) X 18(W) X 8-13(H) 10 Degree Lordotic
• 10840642106862: Expandable Implant, 50(L) X 18(W) X 8-13(H) 10 Degree Lordotic
• 10840642106848: Expandable Implant, 55(L) X 18(W) X 8-13(H) Biconvex
• 10840642106831: Expandable Implant, 50(L) X (18)W X 8-13(H) Biconvex
• 10840642106824: Expandable Implant, 45(L) X (18)W X 8-13(H) Biconvex
• 10840642106817: Expandable Implant, 25(L) X 10(W) X 7-12(H), 8 Degree Lordotic
• 10840642106800: Expandable Implant, 22(L) X 10(W) X 7-12(H), 8 Degree Lordotic
• 10840642106794: Expandable Implant, 25(L) X 10(W) X 7-12(H), Biconvex
• 10840642106787: Expandable Implant, 22(L) X 10(W) X 7-12(H), Biconvex