KIT DUALX TLIF 8 DEG x 8-11MM

GUDID B70712533006004A0

TLIF IMPLANT Lordosis & Heights: 8° x 8-11mm Lateral Length/Width: 21.1 mm Superior - Inferior Height: 11.5mm Anterior -Posterior Length: 33.4mm TLIF SCREW

AMPLIFY SURGICAL, INC.

Metallic spinal fusion cage, sterile Metallic spinal fusion cage, sterile

• Primary Device ID: B70712533006004A0
• NIH Device Record Key: ff9d593b-028f-403d-a259-c8271adf6232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT DUALX TLIF 8 DEG x 8-11MM
• Version Model Number: 12533006004A
• 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: 949-220-1286
• Email: admin@innovasiveinc.com
• Phone: 949-220-1286
• Email: admin@innovasiveinc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B70712533006004A0 [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: 2
• Public Version Date: 2019-05-13
• Device Publish Date: 2019-01-08

On-Brand Devices [KIT DUALX TLIF 8 DEG x 8-11MM]

• B70712533006004A0: TLIF IMPLANT Lordosis & Heights: 8° x 8-11mm Lateral Length/Width: 21.1 mm Superior - Inferior
• B707125330060040: TLIF IMPLANT Lordosis & Heights: 8° x 8-11mm Collapsed Width (mm): 12.32 Expanded Width (mm): 2