FDA UDI
In Commercial Distribution
🇺🇸 United States
RIVA Pedicle Screw System
DI: 00840493419862
·
Model: FG1-16-040350
·
XENIX MEDICAL LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RIVA Pedicle Screw System
- Primary DI
- 00840493419862
- Version / Model
- FG1-16-040350
- Catalog Number
- FG1-16-040350
- Company Name
- XENIX MEDICAL LLC
- Labeler DUNS
- 080386764
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-17
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- e36d1b92-9afe-49da-845a-7f0c56ce78f2
Device Description
Z-ROD, 6.0mm x 350mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66651 | Zinc protoporphyrin transcutaneous optical analyser | An electro-optical device intended to noninvasively measure zinc protoporphyrin (ZnPP) in a patient’s red blood cells to screen for conditions related to increased levels, such as iron deficiency or lead poisoning. It consists of a software-assisted spectroscopy analyser and a hand-held probe, with low-intensity laser light source and sensor, designed to transcutaneously measure ZnPP at the wet vermillion of the lower lip. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840493419862 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251154 | 000 |