FDA UDI
In Commercial Distribution
🇺🇸 United States
SIros-X
DI: M719GSIXFR1050500
·
Model: 1
·
Genesys Orthopedics Systems LLC
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SIros-X
- Primary DI
- M719GSIXFR1050500
- Version / Model
- 1
- Catalog Number
- GSI-XFR105050
- Company Name
- Genesys Orthopedics Systems LLC
- Labeler DUNS
- 017921066
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- 30bd01f2-b781-4e5e-9d20-17a297968845
Device Description
10.5mm x 50mm SIros-X FA Reduction Screw
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
- 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 |
|---|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | Orthopedic | 888.3040 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 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 |
| 64451 | Volatile organic compound array sensor system IVD | An electrically-powered odour detection device intended to be used for the in vitro detection, quantification and/or identification of volatile organic compounds associated with specific disorders or conditions (e.g., cancers) in a clinical specimen, using an array sensor method. The device consists of an array of gas sensors which simultaneously detect changes in electrical resistance in the presence of specific volatile compounds. This system uses an interpretive application software to record and analyse the resulting data from each sensor, and to identify the specific signatures of volatile organic compounds detected. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M719GSIXFR1050500 | HIBCC |
Customer Contacts
- Phone
- 5123817070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252322 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 50 | Millimeter | |
| Outer Diameter | 10.5 | Millimeter |