DUALX TLIF TRIAL 8-11MM

GUDID B707125352000020

DUALX TLIF TRIAL 8-11MM Rev D

AMPLIFY SURGICAL, INC.

Spinal implant trial

• Primary Device ID: B707125352000020
• NIH Device Record Key: 49e7637e-5edb-4939-8f03-76b08369a964
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX TLIF TRIAL 8-11MM
• Version Model Number: 12535200002
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707125352000020 [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

[B707125352000020]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-31
• Device Publish Date: 2019-05-23

On-Brand Devices [DUALX TLIF TRIAL 8-11MM]

• B70712535200002A0: DUALX TLIF TRIAL 8-11MM
• B707125352000020: DUALX TLIF TRIAL 8-11MM Rev D
• B707125354000030: DUALX TLIF TRIAL 8-11MM
• B707125354010030: DUALX TLIF TRIAL 8-11MM