CxHA™ CH141608

GUDID M711CH1416081

HA PEEK, Ta

Innovasis, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M711CH1416081
• NIH Device Record Key: 5ba96904-5d72-4ac5-9449-50147157d691
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CxHA™
• Version Model Number: CH141608
• Catalog Number: CH141608
• 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

Device Dimensions

• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter
• Angle: 8 degree
• Height: 8 Millimeter
• Width: 16 Millimeter
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711CH1416080 [Primary]
HIBCC	M711CH1416081 [Package]; Contains: M711CH1416080; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181115

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

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: 2023-10-12
• Device Publish Date: 2018-09-30

On-Brand Devices [CxHA™]

• M711BTA1620: Cross-linked Polyethylene, Convoluted Polyurethane, Lexan
• M711BTA1590: Al, SST, Nylon, Silicone
• M711LS458160: SST
• M711LS458150: SST
• M711LS458140: SST
• M711LS458130: SST
• M711LS458120: SST
• M711LS458110: SST
• M711LS458100: SST
• M711LS458090: SST
• M711LS458080: SST
• M711LS458070: SST
• M711LS458060: SST
• M711LS458050: SST
• M711LS458040: SST
• M711LS458030: SST
• M711LS458020: SST
• M711LS458010: SST
• M711CH1619121: HA PEEK, Ta
• M711CH1619111: HA PEEK, Ta
• M711CH1619101: HA PEEK, Ta
• M711CH1619091: HA PEEK, Ta
• M711CH1619081: HA PEEK, Ta
• M711CH1619071: HA PEEK, Ta
• M711CH1619061: HA PEEK, Ta
• M711CH1618121: HA PEEK, Ta
• M711CH1618111: HA PEEK, Ta
• M711CH1618101: HA PEEK, Ta
• M711CH1618091: HA PEEK, Ta
• M711CH1618081: HA PEEK, Ta
• M711CH1618071: HA PEEK, Ta
• M711CH1618061: HA PEEK, Ta
• M711CH1517121: HA PEEK, Ta
• M711CH1517111: HA PEEK, Ta
• M711CH1517101: HA PEEK, Ta
• M711CH1517091: HA PEEK, Ta
• M711CH1517081: HA PEEK, Ta
• M711CH1517071: HA PEEK, Ta
• M711CH1517061: HA PEEK, Ta
• M711CH1417121: HA PEEK, Ta
• M711CH1417111: HA PEEK, Ta
• M711CH1417101: HA PEEK, Ta
• M711CH1417081: HA PEEK, Ta
• M711CH1417071: HA PEEK, Ta
• M711CH1417061: HA PEEK, Ta
• M711CH1416121: HA PEEK, Ta
• M711CH1416111: HA PEEK, Ta
• M711CH1416101: HA PEEK, Ta
• M711CH1416091: HA PEEK, Ta
• M711CH1416081: HA PEEK, Ta