DualX Fixed ACME Drawbar LLIF 45mm

GUDID B707128250090

DualX Fixed ACME Drawbar LLIF 45mm

Amplify Surgical, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: B707128250090
• NIH Device Record Key: 366405b7-b1e3-4097-b7c0-e628de5eccfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DualX Fixed ACME Drawbar LLIF 45mm
• Version Model Number: 12825009
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707128250090 [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

[B707128250090]

Moist Heat or Steam Sterilization

[B707128250090]

Moist Heat or Steam Sterilization

[B707128250090]

Moist Heat or Steam Sterilization

[B707128250090]

Moist Heat or Steam Sterilization

[B707128250090]

Moist Heat or Steam Sterilization

[B707128250090]

Moist Heat or Steam Sterilization

[B707128250090]

Moist Heat or Steam Sterilization

[B707128250090]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-20
• Device Publish Date: 2021-08-12

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• 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