DUALX LLIF LOCKOUT SCREW 2 X 50MM

GUDID B707128300090030

DUALX LLIF LOCKOUT SCREW 2 X 50MM

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

• Primary Device ID: B707128300090030
• NIH Device Record Key: c6adaf1e-b261-4336-ba54-f99f161de0d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX LLIF LOCKOUT SCREW 2 X 50MM
• Version Model Number: 12830009003
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707128300090030 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-05-21
• Device Publish Date: 2020-11-09

Devices Manufactured by Amplify Surgical, Inc.

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• B707125355830010 - DUALX DUAL PORT CANNULA 30MM (USA): 2024-04-03 30MM
• 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