Stansion Matrix® C121411
GUDID M711C1214110
INNO Holdings, Inc.
Vertebral body prosthesis, non-sterile| Primary Device ID | M711C1214110 |
| NIH Device Record Key | dbb11aed-dea9-45aa-a65b-b39d9b679f28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stansion Matrix® |
| Version Model Number | C121411 |
| Catalog Number | C121411 |
| 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 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
Device Dimensions
| Length | 23 Millimeter |
| Width | 11 Millimeter |
| Height | 14 Millimeter |
| Length | 23 Millimeter |
| Width | 11 Millimeter |
| Height | 14 Millimeter |
| Length | 23 Millimeter |
| Width | 11 Millimeter |
| Height | 14 Millimeter |
| Length | 23 Millimeter |
| Width | 11 Millimeter |
| Height | 14 Millimeter |
| Length | 23 Millimeter |
| Width | 11 Millimeter |
| Height | 14 Millimeter |
| Length | 23 Millimeter |
| Width | 11 Millimeter |
| Height | 14 Millimeter |
| Length | 23 Millimeter |
| Width | 11 Millimeter |
| Height | 14 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711C1214110 [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 |
[M711C1214110]
Moist Heat or Steam Sterilization
[M711C1214110]
Moist Heat or Steam Sterilization
[M711C1214110]
Moist Heat or Steam Sterilization
[M711C1214110]
Moist Heat or Steam Sterilization
[M711C1214110]
Moist Heat or Steam Sterilization
[M711C1214110]
Moist Heat or Steam Sterilization
[M711C1214110]
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 |
Trademark Results [Stansion Matrix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STANSION MATRIX 77093983 3561658 Live/Registered |
INNOVASIS, INC. 2007-01-29 |
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