PxHA® HA1011225

GUDID M711HA10112250

HA PEEK, Tantalum

Innovasis, Inc.

Polymeric spinal fusion cage, sterile

• Primary Device ID: M711HA10112250
• NIH Device Record Key: 97921f68-8f25-4f98-ab79-e7aa6b79bbfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PxHA®
• Version Model Number: HA1011225
• Catalog Number: HA1011225
• 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: true
• 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
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree
• Width: 10 Millimeter
• Height: 11 Millimeter
• Length: 22 Millimeter
• Angle: 5 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711HA10112250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151785

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: 4
• Public Version Date: 2019-04-15
• Device Publish Date: 2017-04-17

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• M711HA10132200: HA PEEK, Tantalum
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