KIT DUALX PLIF 8 DEG x 10-13MM

GUDID B70712823000006A0

PLIF Lordosis & Heights: 8° x 10-13mm Lateral Width: 21.1 mm Superior - Inferior Height: 13.5mm Anterior -Posterior Length: 33.4mm PLIF SCREW

AMPLIFY SURGICAL, INC.

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

• Primary Device ID: B70712823000006A0
• NIH Device Record Key: 654c4ad7-fd3f-4f88-8d0a-f707e0ca78c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT DUALX PLIF 8 DEG x 10-13MM
• Version Model Number: 12823000006A
• 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	B70712823000006A0 [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 10-13MM]

• B70712823000006A0: PLIF Lordosis & Heights: 8° x 10-13mm Lateral Width: 21.1 mm Superior - Inferior Height: 13.5m
• B707128230000060: PLIF Lordosis & Heights: 8° x 10-13mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Col
• B707128220000060: PLIF Lordosis & Heights: 8° x 10-13mm Collapsed Width (mm): 12.32 Expanded Width (mm): 21.1 Col