WaveForm® A WA4-411215

GUDID 10889981326579

4-Hole No-Profile Interbody, 35mm x 27mm x 12mm, 15 Deg, 3D

Seaspine Orthopedics Corporation

Metallic spinal interbody fusion cage

• Primary Device ID: 10889981326579
• NIH Device Record Key: d0aedab6-692d-42a4-806c-1f81ff93dd5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveForm® A
• Version Model Number: WA4-411215
• Catalog Number: WA4-411215
• Company DUNS: 079840876
• Company Name: Seaspine Orthopedics Corporation
• 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	10889981326579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233694

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-06
• Device Publish Date: 2025-12-29

On-Brand Devices [WaveForm® A]

• 10889981326685: 4-Hole No-Profile Interbody, 39mm x 30mm x 16mm, 15 Deg, 3D
• 10889981326678: 4-Hole No-Profile Interbody, 39mm x 30mm x 16mm, 10 Deg, 3D
• 10889981326661: 4-Hole No-Profile Interbody, 39mm x 30mm x 14mm, 15 Deg, 3D
• 10889981326654: 4-Hole No-Profile Interbody, 39mm x 30mm x 14mm, 10 Deg, 3D
• 10889981326630: 4-Hole No-Profile Interbody, 39mm x 30mm x 12mm, 10 Deg, 3D
• 10889981326616: 4-Hole No-Profile Interbody, 35mm x 27mm x 16mm, 15 Deg, 3D
• 10889981326593: 4-Hole No-Profile Interbody, 35mm x 27mm x 14mm, 15 Deg, 3D
• 10889981326586: 4-Hole No-Profile Interbody, 35mm x 27mm x 14mm, 10 Deg, 3D
• 10889981326579: 4-Hole No-Profile Interbody, 35mm x 27mm x 12mm, 15 Deg, 3D
• 10889981326562: 4-Hole No-Profile Interbody, 35mm x 27mm x 12mm, 10 Deg, 3D
• 10889981326524: 4-Hole No-Profile Interbody, 31mm x 24mm x 14mm, 15 Deg, 3D
• 10889981326494: 4-Hole No-Profile Interbody, 31mm x 24mm x 12mm, 10 Deg, 3D
• 10889981326487: 4-Hole No-Profile Interbody, 31mm x 24mm x 10mm, 10 Deg, 3D