| Primary Device ID | M711LS6890 |
| NIH Device Record Key | 9e690c77-37df-403d-880d-6bfcd26594b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excella Navigation |
| Version Model Number | LS-689 |
| 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 |
| 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 |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711LS6890 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
[M711LS6890]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-17 |
| Device Publish Date | 2023-08-31 |
| 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) |