Excella MIS®
GUDID M711LS5670
Nitinol
Innovasis, Inc.
Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire| Primary Device ID | M711LS5670 |
| NIH Device Record Key | 1739c17e-e8f0-4219-a103-850da1cce7ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excella MIS® |
| Version Model Number | LS-567 |
| Company DUNS | 156567492 |
| Company Name | Innovasis, 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 | |
| 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 Dimensions
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
| Length | 500 Millimeter |
| Outer Diameter | 1.2 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711LS5670 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102248
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
[M711LS5670]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-08 |
| Device Publish Date | 2022-03-31 |
On-Brand Devices [Excella MIS®]
| M711LS3510 | Nitinol |
| M711BTA1030 | Al, SST, Nylon, Silicone |
| M711BTA750 | Polypropylene, Radel, SST |
| M711BTA740 | Polypropylene, Radel, SST |
| M711BTA730 | Polypropylene, Radel, SST |
| M711BTA720 | Polypropylene, Radel, SST |
| M711BTA710 | Polypropylene, Radel, SST |
| M711BTA1630 | Polypropylene, Radel |
| M711BTA1090 | Al, SST, Polypropylene, Nylon |
| M711LS5680 | Nitinol |
| M711LS5670 | Nitinol |
| M711LS5640 | Nitinol |
| M711LS5630 | Nitinol |
| M711BTA880 | Al, SST, Nylon, Silicone |
| M711BTA870 | Al, SST, Nylon, Silicone |
| M711LS2180 | Al, Silicone, SST |
| M711LS2120 | Nitinol |
| M711LS2080 | Ti 6Al 4V (ELI) |
| M711LS1940 | Al, Silicone, SST |
| M711LS1930 | Al, Silicone, SST |
| M711LS1890 | Nitinol |
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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