FDA UDI
In Commercial Distribution
🇺🇸 United States
Ø5.5mm X 45mm PRECONTOURED RODS
DI: B064XMPH21510452
·
Model: XM-PH-215-1045
·
XENCO MEDICAL LLC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ø5.5mm X 45mm PRECONTOURED RODS
- Primary DI
- B064XMPH21510452
- Version / Model
- XM-PH-215-1045
- Company Name
- XENCO MEDICAL LLC
- Labeler DUNS
- 079282130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-06
- Public Version
- 1
- Public Version Date
- 2025-11-14
- Public Version Status
- New
- Public Device Record Key
- 5637d43c-6962-4eb9-b64b-d30e14833201
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | 888.3070 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | 888.3070 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65116 | Bone-screw internal spinal fixation system rod | An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B064XMPH21510452 | HIBCC |