DUALX DUAL PORT OSTEOTOME HOCKEY LEFT 4.0MM

GUDID B707UOT1742410010

LEFT 4.0MM

AMPLIFY SURGICAL, INC.

Orthopaedic osteotome

• Primary Device ID: B707UOT1742410010
• NIH Device Record Key: 18e2d787-95c5-4144-be62-54e3a3af5866
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX DUAL PORT OSTEOTOME HOCKEY LEFT 4.0MM
• Version Model Number: UOT174241001
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707UOT1742410010 [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

[B707UOT1742410010]

Moist Heat or Steam Sterilization

[B707UOT1742410010]

Moist Heat or Steam Sterilization

[B707UOT1742410010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-13
• Device Publish Date: 2026-02-05

Devices Manufactured by AMPLIFY SURGICAL, INC.

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• B707UOT1742410010 - DUALX DUAL PORT OSTEOTOME HOCKEY LEFT 4.0MM: 2026-02-13LEFT 4.0MM
• B707UOT1742410010 - DUALX DUAL PORT OSTEOTOME HOCKEY LEFT 4.0MM: 2026-02-13 LEFT 4.0MM
• B707UOT1742410020 - DUALX DUAL PORT OSTEOTOME HOCKEY RIGHT 4.0MM: 2026-02-13 RIGHT 4.0MM
• B707UOT1752410050 - DUALX DUAL PORT OSTEOTOME 15 CVD 4.0MM: 2026-02-13 4.0MM 15 DEG
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• B70712535588001US0 - DUALX DUAL PORT CANNULA 30MM: 2025-06-06 30MM US MANUFACTURE
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