EVOL®SI Joint Fusion System
GUDID 00841193112237
10.5mm x 040mm EVOL®SI Screw, 3.2
Cutting Edge Spine, LLC
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile| Primary Device ID | 00841193112237 |
| NIH Device Record Key | 45a455ba-1429-4ef7-aae1-57e2fe4425c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EVOL®SI Joint Fusion System |
| Version Model Number | 5005-040T-32 |
| Company DUNS | 069472647 |
| Company Name | Cutting Edge Spine, LLC |
| 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 | true |
| Expiration Date | true |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841193112237 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190025
FDA Product Code
| OUR | Sacroiliac Joint Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
[00841193112237]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-02 |
| Device Publish Date | 2020-08-25 |
On-Brand Devices [EVOL®SI Joint Fusion System]
| 00841193122991 | EVOL®SI, 11.5mm Washer |
| 00841193122984 | EVOL®SI, 10.5mm Washer |
| 00841193122977 | EVOL®SI, 9.5mm Washer |
| 00841193122960 | EVOL®SI, 7.5mm Washer |
| 00841193122953 | 11.5mm x 060mm EVOL®SI Screw |
| 00841193122946 | 11.5mm x 055mm EVOL®SI Screw |
| 00841193122939 | 11.5mm x 050mm EVOL®SI Screw |
| 00841193122922 | 11.5mm x 045mm EVOL®SI Screw |
| 00841193122915 | 11.5mm x 040mm EVOL®SI Screw |
| 00841193122908 | 11.5mm x 035mm EVOL®SI Screw |
| 00841193122892 | 11.5mm x 030mm EVOL®SI Screw |
| 00841193122885 | 11.5mm x 025mm EVOL®SI Screw |
| 00841193122878 | 10.5mm x 060mm EVOL®SI Screw |
| 00841193122861 | 10.5mm x 055mm EVOL®SI Screw |
| 00841193122854 | 10.5mm x 050mm EVOL®SI Screw |
| 00841193122847 | 10.5mm x 045mm EVOL®SI Screw |
| 00841193122830 | 10.5mm x 040mm EVOL®SI Screw |
| 00841193122823 | 10.5mm x 035mm EVOL®SI Screw |
| 00841193122816 | 10.5mm x 030mm EVOL®SI Screw |
| 00841193122809 | 10.5mm x 025mm EVOL®SI Screw |
| 00841193122793 | 9.5mm x 060mm EVOL®SI Screw |
| 00841193122786 | 9.5mm x 055mm EVOL®SI Screw |
| 00841193122779 | 9.5mm x 050mm EVOL®SI Screw |
| 00841193122762 | 9.5mm x 045mm EVOL®SI Screw |
| 00841193122755 | 9.5mm x 040mm EVOL®SI Screw |
| 00841193122748 | 9.5mm x 035mm EVOL®SI Screw |
| 00841193122731 | 9.5mm x 030mm EVOL®SI Screw |
| 00841193122724 | 9.5mm x 025mm EVOL®SI Screw |
| 00841193122717 | 7.5mm x 060mm EVOL®SI Screw |
| 00841193122700 | 7.5mm x 055mm EVOL®SI Screw |
| 00841193122694 | 7.5mm x 050mm EVOL®SI Screw |
| 00841193122687 | 7.5mm x 045mm EVOL®SI Screw |
| 00841193122670 | 7.5mm x 040mm EVOL®SI Screw |
| 00841193122663 | 7.5mm x 035mm EVOL®SI Screw |
| 00841193122656 | EVOL®SI, Power Adapter, 1/4" Sq to Jacobs |
| 00841193122649 | EVOL®SI, Axial, Ratchet Handle, 1/4" Sq |
| 00841193122632 | EVOL®SI, T-Handle, Ratchet, 1/4" Sq |
| 00841193122625 | EVOL®SI, Radiolucent Wire Clamp |
| 00841193122618 | EVOL®SI, 2.4mm Temporary K-Wire |
| 00841193122601 | EVOL®SI, Bone Pusher |
| 00841193122595 | EVOL®SI, Bone Funnel |
| 00841193122588 | EVOL®SI, Insertion Sleeve (Large) |
| 00841193122571 | EVOL®SI, Down-biting, Serrated Curette |
| 00841193122564 | EVOL®SI, Up-biting, Serrated Curette |
| 00841193122557 | EVOL®SI, Screwdriver (T40 Solid) |
| 00841193122540 | EVOL®SI, Screwdriver (T40 Cannulated) |
| 00841193122533 | EVOL®SI, 11.5mm Cannulated Tap |
| 00841193122526 | EVOL®SI, 10.5mm Cannulated Tap |
| 00841193122519 | EVOL®SI, 9.5mm Cannulated Tap |
| 00841193122502 | EVOL®SI, 7.5mm Cannulated Tap |
Trademark Results [EVOL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVOL 98595776 not registered Live/Pending |
Austin Powder Company 2024-06-11 |
 EVOL 98173564 not registered Live/Pending |
Evol, LLC 2023-09-11 |
 EVOL 98173554 not registered Live/Pending |
Evol, LLC 2023-09-11 |
 EVOL 98173548 not registered Live/Pending |
Evol, LLC 2023-09-11 |
 EVOL 98173544 not registered Live/Pending |
Evol, LLC 2023-09-11 |
 EVOL 98173540 not registered Live/Pending |
Evol, LLC 2023-09-11 |
 EVOL 98173532 not registered Live/Pending |
Evol, LLC 2023-09-11 |
 EVOL 98066073 not registered Live/Pending |
Shenzhen Qsun Industrial Co., Ltd. 2023-06-30 |
 EVOL 98012112 not registered Live/Pending |
Shenzhen Qsun Industrial Co., Ltd. 2023-05-24 |
 EVOL 97851676 not registered Live/Pending |
Jalen Cade Johnson 2023-03-22 |
 EVOL 97496795 not registered Live/Pending |
Air Evol LLC 2022-07-11 |
 EVOL 90546499 not registered Live/Pending |
Active Sports, Inc. 2021-02-25 |
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