FDA UDI
In Commercial Distribution
🇺🇸 United States
PressON™
DI: B6785208640
·
Model: 520864
·
NEXUS SPINE, L.L.C.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PressON™
- Primary DI
- B6785208640
- Version / Model
- 520864
- Company Name
- NEXUS SPINE, L.L.C.
- Labeler DUNS
- 028137605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-31
- Public Version
- 4
- Public Version Date
- 2024-09-18
- Public Version Status
- Update
- Public Device Record Key
- 1a6b045c-e922-4c13-98b7-e7c55820613b
Device Description
PressON Rivet
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65114 | Bone-screw internal spinal fixation system connector | An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B6785208640 | HIBCC |