A-Box® AB183412

GUDID M711AB1834120

PEEK, Ta

Innovasis, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M711AB1834120
• NIH Device Record Key: f15d5a08-cb11-4af1-8390-7b8ca36bbc12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A-Box®
• Version Model Number: AB183412
• Catalog Number: AB183412
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Angle: 12 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711AB1834120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121581

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M711AB1834120]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-01-22

On-Brand Devices [A-Box®]

• M711AB2040120: PEEK, Ta
• M711AB2040060: PEEK, Ta
• M711AB2034120: PEEK, Ta
• M711AB2034060: PEEK, Ta
• M711AB2028120: PEEK, Ta
• M711AB2028060: PEEK, Ta
• M711AB1840120: PEEK, Ta
• M711AB1840060: PEEK, Ta
• M711AB1834120: PEEK, Ta
• M711AB1834060: PEEK, Ta
• M711AB1828120: PEEK, Ta
• M711AB1828060: PEEK, Ta
• M711AB1640120: PEEK, Ta
• M711AB1640060: PEEK, Ta
• M711AB1634120: PEEK, Ta
• M711AB1634060: PEEK, Ta
• M711AB1628120: PEEK, Ta
• M711AB1628060: PEEK, Ta
• M711AB1440120: PEEK, Ta
• M711AB1440060: PEEK, Ta
• M711AB1434120: PEEK, Ta
• M711AB1434060: PEEK, Ta
• M711AB1428120: PEEK, Ta
• M711AB1428060: PEEK, Ta
• M711AB1240120: PEEK, Ta
• M711AB1240060: PEEK, Ta
• M711AB1234120: PEEK, Ta
• M711AB1234060: PEEK, Ta
• M711AB1228120: PEEK, Ta
• M711AB1228060: PEEK, Ta
• M711AB1040120: PEEK, Ta
• M711AB1040060: PEEK, Ta
• M711AB1034120: PEEK, Ta
• M711AB1034060: PEEK, Ta
• M711AB1028120: PEEK, Ta
• M711AB1028060: PEEK, Ta
• M711AB0840060: PEEK, Ta
• M711AB0834060: PEEK, Ta
• M711AB0828120: PEEK, Ta
• M711AB0828060: PEEK, Ta
• M711BTA460: Al, SST, Silicone
• M711BTA510: Radel, Tecapro
• M711BTA500: Radel, Tecapro
• M711BTA490: Radel, Tecapro
• M711BTA480: Radel, Tecapro
• M711LAI0300: Silicone, SST
• M711LAI0200: Radel, SST
• M711LAI0100: Ti 6Al 4V (ELI), SST
• M711LAA0900: SST
• M711LA1050: SST