KIT DUALX PLIF 8 DEG x 9-12MM

GUDID B70712823000005A0

PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Lateral Width: 21.1 mm Superior - Inferior Height: 12.5mm Anterior -Posterior Length: 33.4mm PLIF SCREW

AMPLIFY SURGICAL, INC.

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

• Primary Device ID: B70712823000005A0
• NIH Device Record Key: ccd2e33b-148d-4cd7-855e-6cfff166e32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT DUALX PLIF 8 DEG x 9-12MM
• Version Model Number: 12823000005A
• 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	B70712823000005A0 [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 PLIF 8 DEG x 9-12MM]

• B70712823000005A0: PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Lateral Width: 21.1 mm Superior - Inferior Height
• B707128230000050: PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm): 2
• B707128220000050: PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm): 2