FDA UDI
In Commercial Distribution
🇺🇸 United States
RIVA Posterior Fixation System
DI: 00840493413631
·
Model: FG1-20-000010
·
XENIX MEDICAL LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RIVA Posterior Fixation System
- Primary DI
- 00840493413631
- Version / Model
- FG1-20-000010
- Catalog Number
- FG1-20-000010
- Company Name
- XENIX MEDICAL LLC
- Labeler DUNS
- 080386764
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-15
- Public Version
- 1
- Public Version Date
- 2025-08-25
- Public Version Status
- New
- Public Device Record Key
- cfc1926b-5abd-4f4b-8bf3-b144804a0f2a
Device Description
HEAD, POLYAXIAL
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 |
|---|---|---|---|---|
| 66948 | Spinal bone screw head/rod adaptor | A small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. Also known as a reduction head or tulip, it is typically U-shaped with threads to receive a set screw and/or has a hole to allow the rod and/or connector to pass through; it may also facilitate a degree of motion. It is available in various lengths and is made of metal (e.g., surgical steel, titanium alloy) and/or synthetic polymer materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840493413631 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251154 | 000 |