Excella® EP4540
GUDID M711EP45400
Ti 6Al 4V (ELI)
Innovasis, Inc.
Spinal bone screw, non-bioabsorbable| Primary Device ID | M711EP45400 |
| NIH Device Record Key | 5b894405-11e9-4edb-8cfe-4ebf4e99c8fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excella® |
| Version Model Number | EP4540 |
| Catalog Number | EP4540 |
| 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 | |
| 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 | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 4.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711EP45400 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071921
FDA Product Code
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
[M711EP45400]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-05-22 |
| Device Publish Date | 2014-09-17 |
On-Brand Devices [Excella®]
| M711BPS040 | Radel, Tecapro, Al, SST |
| M711BPS030 | Al, SST |
| M711LS0140 | SST |
| M711LA1820 | Radel, SST |
| M711LS1270 | SST |
| M711LS0200 | SST |
| M711LA1540 | Silicone, SST |
| M711LA1510 | Silicone, SST |
| M711LA1810 | Pedicle Screw Alignment Wrench, SST |
| M711LA1710 | Soft Tissue Shield, SST |
| M711LA1130 | Pedicle Marker, Cone, Excella-P, SST |
| M711LA1120 | Pedicle Marker, Cylinder, Excella-P, SST |
| M711LA0100 | Tulip Alignment Wrench, Excella-P,SST |
| M711LS1400 | Finishing Screw Driver, Excella-P, SST |
| M711LS1380 | Locking Cap Inserter, Excella-P, SST |
| M711LS1240 | Cross Connector Driver Assembly, Excella-P, SST |
| M711BR6095010 | Ti 6Al 4V (ELI) |
| M711BR6085010 | Ti 6Al 4V (ELI) |
| M711BR6075010 | Ti 6Al 4V (ELI) |
| M711BR6065010 | Ti 6Al 4V (ELI) |
| M711BR6055010 | Ti 6Al 4V (ELI) |
| M711BR6045010 | Ti 6Al 4V (ELI) |
| M711764600 | Ti 6Al 4V (ELI) |
| M711761200 | Ti 6Al 4V (ELI) |
| M711761100 | Ti 6Al 4V (ELI) |
| M711761000 | Ti 6Al 4V (ELI) |
| M711760900 | Ti 6Al 4V (ELI) |
| M711760800 | Ti 6Al 4V (ELI) |
| M711760700 | Ti 6Al 4V (ELI) |
| M711760600 | Ti 6Al 4V (ELI) |
| M711760550 | Ti 6Al 4V (ELI) |
| M711760500 | Ti 6Al 4V (ELI) |
| M711760450 | Ti 6Al 4V (ELI) |
| M711760400 | Ti 6Al 4V (ELI) |
| M711EP75600 | Ti 6Al 4V (ELI) |
| M711EP75550 | Ti 6Al 4V (ELI) |
| M711EP75500 | Ti 6Al 4V (ELI) |
| M711EP75450 | Ti 6Al 4V (ELI) |
| M711EP75400 | Ti 6Al 4V (ELI) |
| M711EP75350 | Ti 6Al 4V (ELI) |
| M711EP75300 | Ti 6Al 4V (ELI) |
| M711EP70800 | Ti 6Al 4V (ELI) |
| M711EP65600 | Ti 6Al 4V (ELI) |
| M711EP65550 | Ti 6Al 4V (ELI) |
| M711EP65500 | Ti 6Al 4V (ELI) |
| M711EP65450 | Ti 6Al 4V (ELI) |
| M711EP65400 | Ti 6Al 4V (ELI) |
| M711EP65350 | Ti 6Al 4V (ELI) |
| M711EP65300 | Ti 6Al 4V (ELI) |
| M711EP60700 | Ti 6Al 4V (ELI) |
Trademark Results [Excella]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCELLA 98615737 not registered Live/Pending |
Excella Enterprise 2024-06-24 |
 EXCELLA 87790453 5932752 Live/Registered |
Seminis Vegetable Seeds, Inc. 2018-02-08 |
 EXCELLA 87674901 5552438 Live/Registered |
EXCELLA, INC. 2017-11-07 |
 EXCELLA 86265337 5073674 Live/Registered |
QIAGEN BEVERLY, INC. 2014-04-29 |
 EXCELLA 85389110 4476698 Live/Registered |
EXCELLA, INC. 2011-08-04 |
 EXCELLA 85000624 3936937 Live/Registered |
The Pay-O-Matic Corp. 2010-03-29 |
 EXCELLA 79245112 not registered Live/Pending |
Excella GmbH & Co. KG 2018-09-05 |
 EXCELLA 79065882 3752477 Live/Registered |
YKK CORPORATION 2009-01-29 |
 EXCELLA 78910129 not registered Dead/Abandoned |
Kraft Foods Holdings, Inc. 2006-06-16 |
 EXCELLA 78854449 3208432 Dead/Cancelled |
MAG-TEK, INC. 2006-04-05 |
 EXCELLA 78797846 3282611 Live/Registered |
Innovasis, Inc. 2006-01-24 |
 EXCELLA 78591329 3178304 Live/Registered |
EPPENDORF, INC. 2005-03-21 |
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