A-Box® LWI-010
GUDID M711LWI0100
SST
INNO Holdings, Inc.
Orthopaedic implant driver| Primary Device ID | M711LWI0100 |
| NIH Device Record Key | de4b76cd-9f35-4ba9-9017-52f01d020772 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A-Box® |
| Version Model Number | LWI-010 |
| Catalog Number | LWI-010 |
| 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 | 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 |
| 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 | |
| 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 | |
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711LWI0100 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121581
FDA Product Code
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
[M711LWI0100]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-17 |
| Device Publish Date | 2019-07-05 |
Devices Manufactured by INNO Holdings, Inc.
| M711591417121 - HAcancellous™ PEEK-C | 2025-12-17 HAcancellous PEEK-C, 14L x 17W x 12H x 8°, HA PEEK, Ta |
| M711591619121 - HAcancellous™ PEEK-C | 2025-12-17 HAcancellous PEEK-C, 16L x 19W x 12H x 8°, HA PEEK, Ta |
| M71164010 - AxTiHA | 2025-12-17 Ti 6Al 4V (ELI) |
| M71164020 - AxTiHA | 2025-12-17 Ti 6Al 4V (ELI) |
| M711AXT1030080 - Statyx™ | 2025-12-17 AxT, 10H x 30W x 8°, Ti 6Al 4V (ELI), |
| M711AXT1030140 - Statyx™ | 2025-12-17 AxT, 10H x 30W x 14°, Ti 6Al 4V (ELI) |
| M711AXT1036080 - Statyx™ | 2025-12-17 AxT, 10H x 36W x 8°, Ti 6Al 4V (ELI) |
| M711AXT1040080 - Statyx™ | 2025-12-17 AxT, 10H x 40W x 8°, Ti 6Al 4V (ELI) |
Trademark Results [A-Box]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A-BOX 78877528 3707059 Live/Registered |
Innovasis 2006-05-05 |
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