DUALX LLIF TRIAL 10-13MM

GUDID B707128350050040

DUALX LLIF TRIAL 10-13MM

AMPLIFY SURGICAL, INC.

Spinal implant trial

• Primary Device ID: B707128350050040
• NIH Device Record Key: 5c93c25b-b753-491b-bf63-8bbd7d8e4ef4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX LLIF TRIAL 10-13MM
• Version Model Number: 12835005004
• 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: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com
• Phone: 7652695439
• Email: udi@amplifysurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707128350050040 [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

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

[B707128350050040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-05-08

On-Brand Devices [DUALX LLIF TRIAL 10-13MM]

• B70712835005004A0: 10MM X 13MM TRIAL
• B707128350050040: DUALX LLIF TRIAL 10-13MM
• B707128350060040: DUALX LLIF TRIAL 10-13MM