Excella II® E26540
GUDID M711E265400
Ti 6Al 4V (ELI)
Innovasis, Inc.
Spinal bone screw, non-bioabsorbable| Primary Device ID | M711E265400 |
| NIH Device Record Key | bdf5c927-af11-40f8-b8fb-d514b0628353 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excella II® |
| Version Model Number | E26540 |
| Catalog Number | E26540 |
| 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 |
Device Dimensions
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 6.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711E265400 [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 |
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
[M711E265400]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-05-20 |
| Device Publish Date | 2014-09-15 |
On-Brand Devices [Excella II®]
| M711LS1750 | Radel, Silicone, SST |
| M711LS1600 | Al, Silicone, SST |
| M711LS1530 | SST |
| M711LS1470 | SST |
| M711LS0490 | SST |
| M711E2S65300 | Ti 6Al 4V (ELI) |
| M711LS18780 | SST |
| M711LS18770 | SST |
| M711LS18760 | SST |
| M711LS18750 | SST |
| M711LS1860 | SST |
| M711LS1690 | SST |
| M711LS1680 | SST |
| M711LS1670 | SST |
| M711LS1660 | SST |
| M711LS1650 | SST |
| M711LS1450 | SST |
| M711LS1440 | SST |
| M711LS1430 | SST |
| M711LS1420 | SST |
| M711LS1410 | SST |
| M711LA1830 | Al, SST, Silicone |
| M711LS2070 | SST |
| M711LS1960 | Silicone, SST |
| M711LS1910 | SST |
| M711LS1900 | SST |
| M711LS1840 | Radel |
| M711LS1830 | Radel |
| M711LS1820 | SST |
| M711LS1590 | SST |
| M711LS0300 | SST |
| M711LS0250 | SST |
| M711LS0120 | SST |
| M711LS0110 | SST |
| M711LS0100 | SST |
| M711LA1530 | Silicone, SST |
| M711LAT400 | Handle, Torque, 40 in-lb., Al, Silicone, SST |
| M711LA1840 | Universal Ratchet Handle, Custom, Al, SST, Silicone |
| M711LS4410 | Distractor, 6.0mm, 6mm-66mm, SST, Silicone |
| M711LS4400 | Compressor, 6mm, 70mm-20mm RAK SIL INSR, SST, Silicone |
| M711LS2890 | Rod Reducer, SST |
| M711LS2200 | Awl, Cannulated, Palm Handle, Al, Silicone, SST |
| M711LS0510 | Bone Awl, w/ Impact Cap, .146 Tip, Al, Silicone, SST |
| M711E2S85600 | Ti 6Al 4V (ELI) |
| M711E2S85550 | Ti 6Al 4V (ELI) |
| M711E2S85500 | Ti 6Al 4V (ELI) |
| M711E2S85450 | Ti 6Al 4V (ELI) |
| M711E2S85400 | Ti 6Al 4V (ELI) |
| M711E2S85350 | Ti 6Al 4V (ELI) |
| M711E2S85300 | Ti 6Al 4V (ELI) |
Trademark Results [Excella II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCELLA II 77932346 3967294 Live/Registered |
Innovasis Inc. 2010-02-10 |
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