FDA UDI
In Commercial Distribution
🇺🇸 United States
EVOL®SI Joint Fusion System
DI: 00841193124872
·
Model: 5005-050T-32
·
Cutting Edge Spine, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EVOL®SI Joint Fusion System
- Primary DI
- 00841193124872
- Version / Model
- 5005-050T-32
- Company Name
- Cutting Edge Spine, LLC
- Labeler DUNS
- 069472647
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-25
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 7941d17f-5bdc-40e0-97d9-d0ec2ae73690
Device Description
10.5mm x 50mm EVOL®SI Screw, 3.2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61485 | Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated | An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841193124872 | GS1 |
Customer Contacts
- Phone
- 704-243-0892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190025 | 000 |