dualX Graft Delivery Tip (USA)

GUDID B707125341260

DUALX Graft Delivery Tip

AMPLIFY SURGICAL, INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: B707125341260
• NIH Device Record Key: 74e1c27e-ac99-48e1-a284-824cb437254e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dualX Graft Delivery Tip (USA)
• Version Model Number: 12534126
• 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
• 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	B707125341260 [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

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

[B707125341260]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-05-21
• Device Publish Date: 2024-10-07

Devices Manufactured by AMPLIFY SURGICAL, INC.

• B707125341260 - dualX Graft Delivery Tip (USA): 2025-05-21DUALX Graft Delivery Tip
• B707125341260 - dualX Graft Delivery Tip (USA): 2025-05-21 DUALX Graft Delivery Tip
• B70712534146040 - DualX LLIF IMPLANT HOLDER 40mm: 2025-05-21 DUALX LLIF IMPLANT HOLDER 40mm
• B707125341460450 - DualX LLIF IMPLANT HOLDER 45mm: 2025-05-21 DUALX LLIF IMPLANT HOLDER 45mm
• B707125341460550 - DualX LLIF IMPLANT HOLDER 55mm: 2025-05-21 DUALX LLIF IMPLANT HOLDER 55mm
• B707128400060010 - DUALXS T/PLIF LOCKOUT SCREW SHORT: 2025-05-21 DUALXS T/PLIF LOCKOUT SCREW SHORT
• B707128450070 - DUALX LLIF IMPLANT STERILIZATION CADDY: 2025-05-21 LLIF IMPLANT STERILIZATION CADDY
• B707129410010010 - DUALXS T/PLIF 12 DEG x 7-10MM: 2025-05-21 Lordosis & Heights: 12° x 7-10mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm)
• B707128300090010 - DUALX LLIF LOCKOUT SCREW 2 X 40MM: 2025-05-08 DUALX LLIF LOCKOUT SCREW 2 X 40MM