DUALXS T/PLIF 15 DEG x 9-12MM

GUDID B707129410010140

Lordosis & Heights: 15° x 9-12mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 9 Expanded Height (mm): 12

Amplify Surgical, Inc.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: B707129410010140
• NIH Device Record Key: fd378d88-0752-436e-bb01-4a481d30a771
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALXS T/PLIF 15 DEG x 9-12MM
• Version Model Number: 12941001014
• 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
• 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	B707129410010140 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

[B707129410010140]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-23
• Device Publish Date: 2024-01-15

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• B707125355830020 - DUALX DUAL PORT CANNULA 40MM (USA): 2024-04-03 40MM
• B707125355830030 - DUALX DUAL PORT CANNULA 50MM (USA): 2024-04-03 50MM
• B707125355830040 - DUALX DUAL PORT CANNULA 60MM (USA): 2024-04-03 60MM
• B707125355830050 - DUALX DUAL PORT CANNULA 70MM (USA): 2024-04-03 70MM
• B707125355830060 - DUALX DUAL PORTAL CANNULA 80MM (USA): 2024-04-03 80MM
• B707125355830070 - DUALX DUAL PORTAL CANNULA 90MM (USA): 2024-04-03 90MM