FDA UDI
In Commercial Distribution
🇺🇸 United States
SI-RESTORE
DI: 00850073363003
·
Model: 1701-109535
·
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SI-RESTORE
- Primary DI
- 00850073363003
- Version / Model
- 1701-109535
- Company Name
- BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- Labeler DUNS
- 125905168
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-10
- Public Version
- 1
- Public Version Date
- 2025-03-18
- Public Version Status
- New
- Public Device Record Key
- 7b199236-10fa-4515-84e8-fe814b2889f8
Device Description
SI-RESTORE SCREW, 9.5MM x 35MM
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 Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
| 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 | 00850073363003 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182919 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Millimeter | |
| Outer Diameter | 9.5 | Millimeter |