DUALX COUNTER TORQUE HANDLE 2

GUDID B707125351100

Dual X Counter Torque Handle 2

AMPLIFY SURGICAL, INC.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: B707125351100
• NIH Device Record Key: 2d6af1a1-fd56-45ad-8589-ecb125b24221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX COUNTER TORQUE HANDLE 2
• Version Model Number: 12535110
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707125351100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181397

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

[B707125351100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-12
• Device Publish Date: 2025-12-04

Devices Manufactured by AMPLIFY SURGICAL, INC.

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• B707125355740500 - DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA): 2026-03-13 INCLUDES: CANNULA 50MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740600 - DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA): 2026-03-13 INCLUDES: CANNULA 60MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740700 - DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA): 2026-03-13 INCLUDES: CANNULA 70MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740800 - DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA): 2026-03-13 INCLUDES: CANNULA 80MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355740900 - DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA): 2026-03-13 INCLUDES: CANNULA 90MM HEMOSTATIC AGENT DELIVERY TUBE
• B707125355741000 - DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA): 2026-03-13 INCLUDES: CANNULA 100MM HEMOSTATIC AGENT DELIVERY TUBE