DUALX TLIF TRIAL 9-12MM

GUDID B707125354000040

DUALX TLIF TRIAL 9-12MM

AMPLIFY SURGICAL, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: B707125354000040
• NIH Device Record Key: 4a9fdc3f-ed83-4eb4-8827-997898a91cfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX TLIF TRIAL 9-12MM
• Version Model Number: 12535400004
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707125354000040 [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

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

[B707125354000040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-25
• Device Publish Date: 2019-09-17

On-Brand Devices [DUALX TLIF TRIAL 9-12MM]

• B70712535200003A0: DUALX TLIF TRIAL 9-12MM
• B707125352000030: DUALX TLIF TRIAL 9-12MM Rev D
• B707125354000040: DUALX TLIF TRIAL 9-12MM
• B707125354010040: DUALX TLIF TRIAL 9-12MM