Excella 3™ E3N8530
GUDID M711E3N85300
Ti 6Al 4V (ELI)
Innovasis, Inc.
Spinal bone screw, non-bioabsorbable| Primary Device ID | M711E3N85300 |
| NIH Device Record Key | 6ed91e3f-6a63-46b6-99f4-7bae784e494d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excella 3™ |
| Version Model Number | E3N8530 |
| Catalog Number | E3N8530 |
| 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 |
Device Dimensions
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Length | 30 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711E3N85300 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102248
FDA Product Code
| NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
[M711E3N85300]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-05-21 |
| Device Publish Date | 2017-11-17 |
On-Brand Devices [Excella 3™]
| M711BTA1470 | Al, SST, Nylon, Silicone |
| M711BTA1480 | Al, SST, Silicone |
| M711BTA660 | Al, SST, Nylon, Silicone |
| M711BTA640 | Al, SST, Silicone |
| M711E3N85600 | Ti 6Al 4V (ELI) |
| M711E3N85550 | Ti 6Al 4V (ELI) |
| M711E3N85500 | Ti 6Al 4V (ELI) |
| M711E3N85450 | Ti 6Al 4V (ELI) |
| M711E3N85400 | Ti 6Al 4V (ELI) |
| M711E3N85350 | Ti 6Al 4V (ELI) |
| M711E3N85300 | Ti 6Al 4V (ELI) |
| M711E3N75600 | Ti 6Al 4V (ELI) |
| M711E3N75550 | Ti 6Al 4V (ELI) |
| M711E3N75500 | Ti 6Al 4V (ELI) |
| M711E3N75450 | Ti 6Al 4V (ELI) |
| M711E3N75400 | Ti 6Al 4V (ELI) |
| M711E3N75350 | Ti 6Al 4V (ELI) |
| M711E3N75300 | Ti 6Al 4V (ELI) |
| M711E3N65600 | Ti 6Al 4V (ELI) |
| M711E3N65550 | Ti 6Al 4V (ELI) |
| M711E3N65500 | Ti 6Al 4V (ELI) |
| M711E3N65450 | Ti 6Al 4V (ELI) |
| M711E3N65400 | Ti 6Al 4V (ELI) |
| M711E3N65350 | Ti 6Al 4V (ELI) |
| M711E3N65300 | Ti 6Al 4V (ELI) |
| M711E3N65250 | Ti 6Al 4V (ELI) |
| M711E3N55550 | Ti 6Al 4V (ELI) |
| M711E3N55500 | Ti 6Al 4V (ELI) |
| M711E3N55450 | Ti 6Al 4V (ELI) |
| M711E3N55400 | Ti 6Al 4V (ELI) |
| M711E3N55350 | Ti 6Al 4V (ELI) |
| M711E3N55300 | Ti 6Al 4V (ELI) |
| M711E3N55250 | Ti 6Al 4V (ELI) |
| M711E3N475450 | Ti 6Al 4V (ELI) |
| M711E3N475400 | Ti 6Al 4V (ELI) |
| M711E3N475350 | Ti 6Al 4V (ELI) |
| M711E3N475300 | Ti 6Al 4V (ELI) |
| M711E3N475250 | Ti 6Al 4V (ELI) |
| M711BTA760 | Excella 3 Cross Link Caddy, Polypropylene, Radel |
Trademark Results [Excella 3]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCELLA 3 87528460 5395769 Live/Registered |
Innovasis, Inc. 2017-07-14 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.