Meridian® WaveForm® A WA4-411010

GUDID 10889981326333

4-Hole No-Profile Interbody, 35mm x 27mm x 10mm, 10 Deg, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 10889981326333
• NIH Device Record Key: 4a07deac-4918-49b3-9360-d03bce670260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meridian® WaveForm® A
• Version Model Number: WA4-411010
• Catalog Number: WA4-411010
• 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	10889981326333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233694

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-13
• Device Publish Date: 2024-12-05

On-Brand Devices [Meridian® WaveForm® A]

• 10889981326463: 4-Hole No-Profile Interbody, 39mm x 30mm x 16mm, 15 Deg, 3D
• 10889981326456: 4-Hole No-Profile Interbody, 39mm x 30mm x 16mm, 10 Deg, 3D
• 10889981326449: 4-Hole No-Profile Interbody, 39mm x 30mm x 14mm, 15 Deg, 3D
• 10889981326432: 4-Hole No-Profile Interbody, 39mm x 30mm x 14mm, 10 Deg, 3D
• 10889981326425: 4-Hole No-Profile Interbody, 39mm x 30mm x 12mm, 15 Deg, 3D
• 10889981326418: 4-Hole No-Profile Interbody, 39mm x 30mm x 12mm, 10 Deg, 3D
• 10889981326401: 4-Hole No-Profile Interbody, 39mm x 30mm x 10mm, 10 Deg, 3D
• 10889981326395: 4-Hole No-Profile Interbody, 35mm x 27mm x 16mm, 15 Deg, 3D
• 10889981326388: 4-Hole No-Profile Interbody, 35mm x 27mm x 16mm, 10 Deg, 3D
• 10889981326371: 4-Hole No-Profile Interbody, 35mm x 27mm x 14mm, 15 Deg, 3D
• 10889981326364: 4-Hole No-Profile Interbody, 35mm x 27mm x 14mm, 10 Deg, 3D
• 10889981326357: 4-Hole No-Profile Interbody, 35mm x 27mm x 12mm, 15 Deg, 3D
• 10889981326340: 4-Hole No-Profile Interbody, 35mm x 27mm x 12mm, 10 Deg, 3D
• 10889981326333: 4-Hole No-Profile Interbody, 35mm x 27mm x 10mm, 10 Deg, 3D
• 10889981326326: 4-Hole No-Profile Interbody, 31mm x 24mm x 16mm, 15 Deg, 3D
• 10889981326319: 4-Hole No-Profile Interbody, 31mm x 24mm x 16mm, 10 Deg, 3D
• 10889981326302: 4-Hole No-Profile Interbody, 31mm x 24mm x 14mm, 15 Deg, 3D
• 10889981326296: 4-Hole No-Profile Interbody, 31mm x 24mm x 14mm, 10 Deg, 3D
• 10889981326289: 4-Hole No-Profile Interbody, 31mm x 24mm x 12mm, 15 Deg, 3D
• 10889981326272: 4-Hole No-Profile Interbody, 31mm x 24mm x 12mm, 10 Deg, 3D
• 10889981326265: 4-Hole No-Profile Interbody, 31mm x 24mm x 10mm, 10 Deg, 3D