Excella 3® E37540
GUDID M711E375400
Ti 6Al 4V (ELI)
Innovasis, Inc.
Spinal bone screw, non-bioabsorbable| Primary Device ID | M711E375400 |
| NIH Device Record Key | 1ac27db2-8bb2-434f-9d40-5312db8c590c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excella 3® |
| Version Model Number | E37540 |
| Catalog Number | E37540 |
| Company DUNS | 156567492 |
| Company Name | Innovasis, 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 | 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 |
Device Dimensions
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711E375400 [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 |
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
[M711E375400]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-05-20 |
| Device Publish Date | 2019-07-05 |
On-Brand Devices [Excella 3®]
| M711E385600 | Ti 6Al 4V (ELI) |
| M711E385550 | Ti 6Al 4V (ELI) |
| M711E385500 | Ti 6Al 4V (ELI) |
| M711E385450 | Ti 6Al 4V (ELI) |
| M711E385400 | Ti 6Al 4V (ELI) |
| M711E385350 | Ti 6Al 4V (ELI) |
| M711E385300 | Ti 6Al 4V (ELI) |
| M711E375600 | Ti 6Al 4V (ELI) |
| M711E375550 | Ti 6Al 4V (ELI) |
| M711E375500 | Ti 6Al 4V (ELI) |
| M711E375450 | Ti 6Al 4V (ELI) |
| M711E375400 | Ti 6Al 4V (ELI) |
| M711E375350 | Ti 6Al 4V (ELI) |
| M711E375300 | Ti 6Al 4V (ELI) |
| M711E365600 | Ti 6Al 4V (ELI) |
| M711E365550 | Ti 6Al 4V (ELI) |
| M711E365500 | Ti 6Al 4V (ELI) |
| M711E365450 | Ti 6Al 4V (ELI) |
| M711E365400 | Ti 6Al 4V (ELI) |
| M711E365350 | Ti 6Al 4V (ELI) |
| M711E365300 | Ti 6Al 4V (ELI) |
| M711E365250 | Ti 6Al 4V (ELI) |
| M711E355550 | Ti 6Al 4V (ELI) |
| M711E355500 | Ti 6Al 4V (ELI) |
| M711E355450 | Ti 6Al 4V (ELI) |
| M711E355400 | Ti 6Al 4V (ELI) |
| M711E355350 | Ti 6Al 4V (ELI) |
| M711E355300 | Ti 6Al 4V (ELI) |
| M711E355250 | Ti 6Al 4V (ELI) |
| M711E3475450 | Ti 6Al 4V (ELI) |
| M711E3475400 | Ti 6Al 4V (ELI) |
| M711E3475350 | Ti 6Al 4V (ELI) |
| M711E3475300 | Ti 6Al 4V (ELI) |
| M711E3475250 | Ti 6Al 4V (ELI) |
| M711ECC75600 | Ti 6Al 4V (ELI) |
| M711ECC75550 | Ti 6Al 4V (ELI) |
| M711ECC75500 | Ti 6Al 4V (ELI) |
| M711ECC75450 | Ti 6Al 4V (ELI) |
| M711ECC75400 | Ti 6Al 4V (ELI) |
| M711ECC75350 | Ti 6Al 4V (ELI) |
| M711ECC75300 | Ti 6Al 4V (ELI) |
| M711ECC65600 | Ti 6Al 4V (ELI) |
| M711ECC65550 | Ti 6Al 4V (ELI) |
| M711ECC65500 | Ti 6Al 4V (ELI) |
| M711ECC65450 | Ti 6Al 4V (ELI) |
| M711ECC65400 | Ti 6Al 4V (ELI) |
| M711ECC65350 | Ti 6Al 4V (ELI) |
| M711ECC65300 | Ti 6Al 4V (ELI) |
| M711ECC65250 | Ti 6Al 4V (ELI) |
| M711ECC55550 | Ti 6Al 4V (ELI) |
Trademark Results [Excella 3]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCELLA 3 87528460 5395769 Live/Registered |
Innovasis, Inc. 2017-07-14 |
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