Excella MIS® LS-195
GUDID M711LS1950
Silicone, SST
INNO Holdings, Inc.
Orthopaedic rod reducer| Primary Device ID | M711LS1950 |
| NIH Device Record Key | d0940dd1-352f-4221-9027-672f22555f1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excella MIS® |
| Version Model Number | LS-195 |
| Catalog Number | LS-195 |
| 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 |
| 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 | M711LS1950 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102248
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
Moist Heat or Steam Sterilization
[M711LS1950]
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 | 2018-01-31 |
On-Brand Devices [Excella MIS®]
| M711LS4680 | Nitinol |
| M711LS4670 | Nitinol |
| M711LS2780 | SST |
| M711LS2770 | SST |
| M711LS2760 | Silicone, SST |
| M711LS2210 | Al, Silicone, SST |
| M711LS2190 | SST |
| M711LS2140 | Silicone, SST |
| M711LS2130 | Al, Silicone, SST |
| M711LS1990 | Al, Silicone, SST |
| M711LS1980 | Al, Silicone, SST |
| M711LS1970 | SST |
| M711LS1950 | Silicone, SST |
| M711LS1920 | SST |
| M711LS1880 | Al, Silicone, SST |
| M711LS1850 | Radel, SST |
| M711LS1800 | Al, Silicone, SST |
| M711LS1770 | SST |
| M711LS1760 | Ti 6Al 4V (ELI) |
Trademark Results [Excella MIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCELLA MIS 86356132 5023083 Live/Registered |
Innovasis, Inc. 2014-08-04 |
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