Leva® Anterior Interbody System 11-0617

GUDID 10840642112498

Modular Spacer, 26 mm (W) x 26 mm (L) x 21 mm (H), 8° Lordotic

Spine Wave, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 10840642112498
• NIH Device Record Key: 356c74d7-efe8-43ce-9f06-a7e26eeb081c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leva® Anterior Interbody System
• Version Model Number: 11-0617
• Catalog Number: 11-0617
• 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: GUIDID@spinewave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642112498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161993

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, 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: 2017-08-10

On-Brand Devices [Leva® Anterior Interbody System]

• 10840642118063: Modular Spacer, 38 mm (W) x 28 mm (L) x 21 mm (H), 15° Lordotic
• 10840642118056: Modular Spacer, 38 mm (W) x 28 mm (L) x 19 mm (H), 15° Lordotic
• 10840642118049: Modular Spacer, 38 mm (W) x 28 mm (L) x 17 mm (H), 15° Lordotic
• 10840642118032: Modular Spacer, 38 mm (W) x 28 mm (L) x 15 mm (H), 15° Lordotic
• 10840642118025: Modular Spacer, 38 mm (W) x 28 mm (L) x 13 mm (H), 15° Lordotic
• 10840642118018: Modular Spacer, 38 mm (W) x 28 mm (L) x 11 mm (H), 15° Lordotic
• 10840642118001: Modular Spacer, 38 mm (W) x 28 mm (L) x 9 mm (H), 15° Lordotic
• 10840642117998: Modular Spacer, 38 mm (W) x 28 mm (L) x 21 mm (H), 8° Lordotic
• 10840642117981: Modular Spacer, 38 mm (W) x 28 mm (L) x 19 mm (H), 8° Lordotic
• 10840642117974: Modular Spacer, 38 mm (W) x 28 mm (L) x 17 mm (H), 8° Lordotic
• 10840642117967: Modular Spacer, 38 mm (W) x 28 mm (L) x 15 mm (H), 8° Lordotic
• 10840642117950: Modular Spacer, 38 mm (W) x 28 mm (L) x 13 mm (H), 8° Lordotic
• 10840642117943: Modular Spacer, 38 mm (W) x 28 mm (L) x 11 mm (H), 8° Lordotic
• 10840642117936: Modular Spacer, 38 mm (W) x 28 mm (L) x 9 mm (H), 8° Lordotic
• 10840642117929: Modular Spacer, 34 mm (W) x 28 mm (L) x 21 mm (H), 15° Lordotic
• 10840642117912: Modular Spacer, 34 mm (W) x 28 mm (L) x 19 mm (H), 15° Lordotic
• 10840642117905: Modular Spacer, 34 mm (W) x 28 mm (L) x 17 mm (H), 15° Lordotic
• 10840642117899: Modular Spacer, 34 mm (W) x 28 mm (L) x 15 mm (H), 15° Lordotic
• 10840642117882: Modular Spacer, 34 mm (W) x 28 mm (L ) x 13 mm (H), 15° Lordotic
• 10840642117875: Modular Spacer, 34 mm (W) x 28 mm (L) x 11 mm (H), 15° Lordotic
• 10840642117868: Modular Spacer, 34 mm (W) x 28 mm (L) x 9 mm (H), 15° Lordotic
• 10840642117851: Modular Spacer, 34 mm (W) x 28 mm (L) x 21 mm (H), 8° Lordotic
• 10840642117844: Modular Spacer, 34 mm (W) x 28 mm (L) x 19 mm (H), 8° Lordotic
• 10840642117837: Modular Spacer, 34 mm (W) x 28 mm (L) x 17 mm (H), 8° Lordotic
• 10840642117820: Modular Spacer, 34 mm (W) x 28 mm (L) x 15 mm (H), 8° Lordotic
• 10840642117813: Modular Spacer, 34 mm (W) x 28 mm (L) x 13 mm (H), 8° Lordotic
• 10840642117806: Modular Spacer, 34 mm (W) x 28 mm (L) x 11 mm (H), 8° Lordotic
• 10840642117790: Modular Spacer, 34 mm (W) x 28 mm (L) x 9 mm (H), 8° Lordotic
• 10840642117516: Modular Spacer, 30 mm (W) x 26 mm (L) x 21 mm (H), 15° Lordotic
• 10840642117509: Modular Spacer, 30 mm (W) x 26 mm (L) x 19 mm (H), 15° Lordotic
• 10840642117493: Modular Spacer, 30 mm (W) x 26 mm (L) x 17 mm (H), 15° Lordotic
• 10840642117486: Modular Spacer, 30 mm (W) x 26 mm (L) x 15 mm (H), 15° Lordotic
• 10840642117479: Modular Spacer, 30 mm (W) x 26 mm (L) x 13 mm (H), 15° Lordotic
• 10840642117462: Modular Spacer, 30 mm (W) x 26 mm (L) x 11 mm (H), 15° Lordotic
• 10840642117455: Modular Spacer, 30 mm (W) x 26 mm (L) x 9 mm (H), 15° Lordotic
• 10840642117448: Modular Spacer, 30 mm (W) x 26 mm (L) x 21 mm (H), 8° Lordotic
• 10840642117431: Modular Spacer, 30 mm (W) x 26 mm (L) x 19 mm (H), 8° Lordotic
• 10840642117424: Modular Spacer, 30 mm (W) x 26 mm (L) x 17 mm (H), 8° Lordotic
• 10840642117417: Modular Spacer, 30 mm (W) x 26 mm (L) x 15 mm (H), 8° Lordotic
• 10840642117400: Modular Spacer, 30 mm (W) x 26 mm (L) x 13 mm (H), 8° Lordotic
• 10840642117394: Modular Spacer, 30 mm (W) x 26 mm (L) x 11 mm (H), 8° Lordotic
• 10840642117387: Modular Spacer, 30 mm (W) x 26 mm (L) x 9 mm (H), 8° Lordotic
• 10840642112566: Modular Spacer, 26 mm (W) x 26 mm (L) x 21 mm (H), 15° Lordotic
• 10840642112559: Modular Spacer, 26 mm (W) x 26 mm (L) x 19 mm (H), 15° Lordotic
• 10840642112542: Modular Spacer, 26 mm (W) x 26 mm (L) x 17 mm (H), 15° Lordotic
• 10840642112535: Modular Spacer, 26 mm (W) x 26 mm (L) x 15 mm (H), 15° Lordotic
• 10840642112528: Modular Spacer, 26 mm (W) x 26 mm (L) x 13 mm (H), 15° Lordotic
• 10840642112511: Modular Spacer, 26 mm (W) x 26 mm (L) x 11 mm (H), 15° Lordotic
• 10840642112504: Modular Spacer, 26 mm (W) x 26 mm (L) x 9 mm (H), 15° Lordotic
• 10840642112498: Modular Spacer, 26 mm (W) x 26 mm (L) x 21 mm (H), 8° Lordotic