KIT DUALX LLIF 7-9MM x 0 DEG x 45MM

GUDID B707128330050020

LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 45mm Collapsed Width (mm): 13.34 Expanded Width (mm): 22 Collapsed Height (mm): 6.5 Expanded Height (mm): 9.5 Collapsed Length (mm): 53.76 Expanded Length (mm): 46.8 LLIF SCREW - 45MM

AMPLIFY SURGICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: B707128330050020
• NIH Device Record Key: 3260d1a2-ca61-416a-ba18-d61840734e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT DUALX LLIF 7-9MM x 0 DEG x 45MM
• Version Model Number: 12833005002
• 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	B707128330050020 [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: 2019-05-13

On-Brand Devices [KIT DUALX LLIF 7-9MM x 0 DEG x 45MM]

• B70712833005002A0: LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 45mm Lateral Width: 46.8mm
• B707128330050020: LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 7-9mm x 0° x 45mm Collapsed Width (mm):