DUALX LLIF 10-13MM x 7 DEG x 50MM

GUDID B707128310070130

LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 50mm Collapsed Width (mm): 13.34 Expanded Width (mm): 22 Collapsed Height (mm): 10.5 Expanded Height (mm): 13.5 Collapsed Length (mm): 58.76 Expanded Length (mm): 51.8

AMPLIFY SURGICAL, INC.

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• Primary Device ID: B707128310070130
• NIH Device Record Key: b1b73aff-e393-44a2-8bcd-41ac34efbc07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUALX LLIF 10-13MM x 7 DEG x 50MM
• Version Model Number: 12831007013
• 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	B707128310070130 [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: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-07-25

On-Brand Devices [DUALX LLIF 10-13MM x 7 DEG x 50MM]

• B70712831007013A0: LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 50mm Lateral Width: 51.8
• B707128310070130: LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 50mm Collapsed Width (mm)