KIT DUALX TLIF 8 DEG x 10-13MM

GUDID B707125330060060

TLIF IMPLANT Lordosis & Heights: 8° x 10-13mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Collapsed Height (mm): 10.21 Expanded Height (mm): 13.5 Collapsed Length (mm): 39.47 Expanded Length (mm): 33.4 TLIF SCREW

AMPLIFY SURGICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: B707125330060060
• NIH Device Record Key: 4a46e06b-0653-4e92-af01-35325f907cb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT DUALX TLIF 8 DEG x 10-13MM
• Version Model Number: 12533006006
• 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
• Phone: 7652675439
• Email: udi@amplifysurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B707125330060060 [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: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-05-10

On-Brand Devices [KIT DUALX TLIF 8 DEG x 10-13MM]

• B70712533006006A0: TLIF IMPLANT Lordosis & Heights: 8° x 10-13mm Lateral Length/Width: 21.1 mm Superior - Inferior
• B707125330060060: TLIF IMPLANT Lordosis & Heights: 8° x 10-13mm Collapsed Width (mm): 12.32 Expanded Width (mm):