PxHA­® HA1215280

GUDID M711HA12152800

HA PEEK, Tantalum

Innovasis, Inc.

Polymeric spinal fusion cage, sterile

• Primary Device ID: M711HA12152800
• NIH Device Record Key: ce15731c-1bde-420b-b601-10f9dbe09603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PxHA­®
• Version Model Number: HA1215280
• Catalog Number: HA1215280
• 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

Device Dimensions

• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree
• Width: 12 Millimeter
• Height: 15 Millimeter
• Length: 28 Millimeter
• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711HA12152800 [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

Devices Manufactured by Innovasis, Inc.

• M711CCR0060 - C-Box®: 2025-06-09 6mm Cervical Cage Rasp, SST
• M711CCR0070 - C-Box®: 2025-06-09 7mm Cervical Cage Rasp, SST
• M711CCR0080 - C-Box®: 2025-06-09 8mm Cervical Cage Rasp, SST
• M711CCR0090 - C-Box®: 2025-06-09 9mm Cervical Cage Rasp, SST
• M711CCR0100 - C-Box®: 2025-06-09 10mm Cervical Cage Rasp, SST
• M711CCR0110 - C-Box®: 2025-06-09 11mm Cervical Cage Rasp, SST
• M711CCR0120 - C-Box®: 2025-06-09 12mm Cervical Cage Rasp, SST
• M711CCS0060 - C-Box®: 2025-06-09 6mm Cervical Cage Sizer, SST