FDA UDI
In Commercial Distribution
🇺🇸 United States
iFuse TORQ Implant System
DI: 00810055520053
·
Model: 10045T
·
Si-Bone Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iFuse TORQ Implant System
- Primary DI
- 00810055520053
- Version / Model
- 10045T
- Company Name
- Si-Bone Inc.
- Labeler DUNS
- 830127168
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-08
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- f6b6003e-ca0c-4471-94b1-3e017d012537
Device Description
10.0mm x 45mm iFuse-TORQ
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58808 | Sacroiliac joint transarticular fixation/arthrodesis implant, coated | 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 metal [e.g., titanium (Ti)] with a porous plasma spray coating, and typically in the form of a cylinder or rod, possibly with a triangular cross-section. 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 | 00810055520053 | GS1 |
Customer Contacts
- Phone
- 855-884-3873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203247 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 45 | Millimeter | |
| Outer Diameter | 10 | Millimeter |