DUALXS T/PLIF 8 DEG x 7-9MM

GUDID B707129410010040

Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm): 9

Amplify Surgical, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: B707129410010040
• NIH Device Record Key: 31701b08-2d26-422a-a665-fb858466b90a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALXS T/PLIF 8 DEG x 7-9MM
• Version Model Number: 12941001004
• Company DUNS: 081021000
• Company Name: Amplify Surgical, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com
• Phone: 7652675439
• Email: udi@amplifysurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707129410010040 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

[B707129410010040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-28
• Device Publish Date: 2024-06-20

On-Brand Devices [DUALXS T/PLIF 8 DEG x 7-9MM]

• B707129410010030: Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Heigh
• B707129410010040: Lordosis & Heights: 8° x 7-9mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Heigh