HAcancellous™ PEEK-C

GUDID M711591619121

HAcancellous PEEK-C, 16L x 19W x 12H x 8°, HA PEEK, Ta

INNO Holdings, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M711591619121
• NIH Device Record Key: bae0c5c3-34fd-4bd0-b968-79d2d626a1a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAcancellous™ PEEK-C
• Version Model Number: 59-161912
• Company DUNS: 141620464
• Company Name: INNO Holdings, 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: 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
• 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

• Length: 16 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Width: 19 Millimeter
• Length: 16 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Width: 19 Millimeter
• Length: 16 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Width: 19 Millimeter
• Length: 16 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Width: 19 Millimeter
• Length: 16 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Width: 19 Millimeter
• Length: 16 Millimeter
• Height: 12 Millimeter
• Angle: 8 degree
• Width: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711591619120 [Primary]
HIBCC	M711591619121 [Package]; Contains: M711591619120; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220875

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: 2025-12-17
• Device Publish Date: 2023-11-30

On-Brand Devices [HAcancellous™ PEEK-C]

• M711591619121: HAcancellous PEEK-C, 16L x 19W x 12H x 8°, HA PEEK, Ta
• M711591417121: HAcancellous PEEK-C, 14L x 17W x 12H x 8°, HA PEEK, Ta