Stansion Matrix® B121409

GUDID M711B1214090

INNO Holdings, Inc.

Vertebral body prosthesis, non-sterile

• Primary Device ID: M711B1214090
• NIH Device Record Key: d12df6d9-6020-40ee-8698-ccb194437a69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stansion Matrix®
• Version Model Number: B121409
• Catalog Number: B121409
• 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: 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: 26 Millimeter
• Width: 9 Millimeter
• Height: 14 Millimeter
• Length: 26 Millimeter
• Width: 9 Millimeter
• Height: 14 Millimeter
• Length: 26 Millimeter
• Width: 9 Millimeter
• Height: 14 Millimeter
• Length: 26 Millimeter
• Width: 9 Millimeter
• Height: 14 Millimeter
• Length: 26 Millimeter
• Width: 9 Millimeter
• Height: 14 Millimeter
• Length: 26 Millimeter
• Width: 9 Millimeter
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711B1214090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042600

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[M711B1214090]

Moist Heat or Steam Sterilization

[M711B1214090]

Moist Heat or Steam Sterilization

[M711B1214090]

Moist Heat or Steam Sterilization

[M711B1214090]

Moist Heat or Steam Sterilization

[M711B1214090]

Moist Heat or Steam Sterilization

[M711B1214090]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-12-17
• Device Publish Date: 2015-04-15

On-Brand Devices [Stansion Matrix®]

• M711C1214110: C121411
• M711C1214090: C121409
• M711C1214070: C121407
• M711C1012090: C101209
• M711C1012070: C101207
• M711C0810070: C081007
• M711C0608070: C060807
• M711B1214110: B121411
• M711B1214090: B121409
• M711B1214070: B121407
• M711B1012090: B101209
• M711B1012070: B101207
• M711B0810070: B081007
• M711B0608070: B060807