Leva® Anterior Expandable Spacer System 10-0315

GUDID 10840642111262

Small/Medium Inserter Tip

Spine Wave, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 10840642111262
• NIH Device Record Key: 4d717dd9-1c14-4e7e-b0c6-e983cf1765d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leva® Anterior Expandable Spacer System
• Version Model Number: 10-0315
• Catalog Number: 10-0315
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642111262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163246

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-04-30

On-Brand Devices [Leva® Anterior Expandable Spacer System]

• 10840642111293: Large/Extra Large Removal Instrument
• 10840642111286: Small/Medium Removal Instrument
• 10840642111279: Large/Extra Large Inserter Tip
• 10840642111262: Small/Medium Inserter Tip
• 10840642111255: Inserter Handle
• 10840642109351: Spacer, 38 mm (W) x 30 mm (D) x 19 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109344: Spacer, 38 mm (W) x 30 mm (D) x 17 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109337: Spacer, 38 mm (W) x 30 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109320: Spacer, 26 mm (W) x 26 mm (D) x 19 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109313: Spacer, 26 mm (W) x 26 mm (D) x 17 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109306: Spacer, 26 mm (W) x 26 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109290: Spacer, 34 mm (W) x 30 mm (D) x 19 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109283: Spacer, 34 mm (W) x 30 mm (D) x 17 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109276: Spacer, 34 mm (W) x 30 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109269: Spacer, 30 mm (W) x 28 mm (D) x 19 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109252: Spacer, 30 mm (W) x 28 mm (D) x 17 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109245: Spacer, 30 mm (W) x 28 mm (D) x 15 mm (H), 8° Lordotic, 4 mm Expansion
• 10840642109238: Spacer, 38 mm (W) x 30 mm (D) x 19 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109221: Spacer, 38 mm (W) x 30 mm (D) x 17 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109214: Spacer, 38 mm (W) x 30 mm (D) x 15 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109207: Spacer, 26 mm (W) x 26 mm (D) x 19 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109191: Spacer, 26 mm (W) x 26 mm (D) x 17 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109184: Spacer, 26 mm (W) x 26 mm (D) x 15 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109177: Spacer, 34 mm (W) x 30 mm (D) x 19 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109160: Spacer, 34 mm (W) x 30 mm (D) x 17 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109153: Spacer, 34 mm (W) x 30 mm (D) x 15 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109146: Spacer, 30 mm (W) x 28 mm (D) x 19 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109139: Spacer, 30 mm (W) x 28 mm (D) x 17 mm (H), 15° Lordotic, 4 mm Expansion
• 10840642109122: Spacer, 30 mm (W) x 28 mm (D) x 15 mm (H), 15° Lordotic, 4 mm Expansion