C-Box® CC-002

GUDID M711CC0020

SST

INNO Holdings, Inc.

Spinal implant trial

• Primary Device ID: M711CC0020
• NIH Device Record Key: 1d573485-b831-498f-a256-8f3f408d4c0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Box®
• Version Model Number: CC-002
• Catalog Number: CC-002
• Company DUNS: 141620464
• Company Name: INNO Holdings, 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: false
• Lot Batch: false
• Serial Number: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M711CC0020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132991

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[M711CC0020]

Moist Heat or Steam Sterilization

[M711CC0020]

Moist Heat or Steam Sterilization

[M711CC0020]

Moist Heat or Steam Sterilization

[M711CC0020]

Moist Heat or Steam Sterilization

[M711CC0020]

Moist Heat or Steam Sterilization

[M711CC0020]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-12-17
• Device Publish Date: 2018-01-31

On-Brand Devices [C-Box®]

• M711CCI010: SST
• M711CC0120: 12.5 x 12 x 13.5mm Cervical Cage Sizer, SST
• M711CC0050: SST
• M711CC0020: SST
• M711CC0010: SST