Leva® Spacer System 10-7241.3

GUDID 10840642125375

PX Blue Link Assembly, Tabbed

Spine Wave, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 10840642125375
• NIH Device Record Key: 70ddc827-73f6-45ed-96af-66798e2aef2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leva® Spacer System
• Version Model Number: 10-7241.3
• Catalog Number: 10-7241.3
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642125375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153222

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[10840642125375]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-01-08

On-Brand Devices [Leva® Spacer System]

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• 10840642125382: PX Purple Link Assembly, Tabbed
• 10840642125375: PX Blue Link Assembly, Tabbed
• 10840642125368: PX Green Link Assembly, Tabbed
• 10840642125351: PX White Link Assembly, Tabbed
• 10840642117370: PX White Inserter Assembly
• 10840642117363: PX Green/Blue Inserter Assembly
• 10840642117356: PX Purple/Brown Inserter Assembly
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• 10840642108088: Leva® PX Outer Handle Assembly 22mm X 7-8-9mm
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• 10840642108064: Leva® PX Inserter, 25 x 7, 8, 9mm
• 10840642108057: Leva® PX Link Assembly, Blue
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• 10840642108033: Leva® PX Link Assembly
• 10840642108026: Leva® PX Inserter Assembly
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• 10840642102659: Expandable Implant 25mm x 10mm x 15mm 10 Degree Lordotic
• 10840642102642: Expandable Implant 25mm x 10mm x 14mm 10 Degree Lordotic
• 10840642102635: Expandable Implant 25mm x 10mm x 13mm 10 Degree Lordotic
• 10840642102628: Expandable Implant 25mm x 10mm x 12mm 10 Degree Lordotic