Swedge Pedicle Screw Fixation System
- Primary DI
- B515RSTT6000
- Brand
- Swedge Pedicle Screw Fixation System
- Company
- SPINAL RESOURCES, INC.
- Model
- RSTT-600
- Device description
- Rod, STANDARD, Transition, Titanium, Straight, x 600mm
- Published
- 2026-11-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
Code, Name table| Code | Name |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| B515RSTT6000 | Primary | HIBCC | 0 | |
Sterilization Methods#
Method table| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 018255727
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
Primary DI, Brand, Model table| Primary DI | Brand | Model | Catalog | Published |
|---|
| B515RSST60500 | Swedge Pedicle Screw Fixation System | RSST60-500 | | 2026-11-02 |
| B515RSTT47555600 | Swedge Pedicle Screw Fixation System | RSTT47555-600 | | 2026-11-02 |
| B515RSCTT5055070 | Swedge Curved, Transition, Titanium Rod 70mm | RSCTT5055-070 | | 2026-10-13 |
| B515RSCTT5055080 | Swedge Curved, Transition, Titanium, Rod | RSCTT5055-080 | | 2026-10-13 |
| B515RSTT47555045 | Swedge Pedicle Screw Fixation System | RSTT47555-045 | | 2026-10-13 |
| B515LC020 | Locking Cap (Set Screw) | LC-02 | | 2026-05-15 |
| B515NCRTT475550060 | Swedge Rod, Hyper-Lordotic Curved, Transition | NCRTT47555-060 | | 2026-05-15 |
| B515NCRTT475550070 | Swedge Rod, Hyper-Lordotic Curved, Transition | NCRTT47555-070 | | 2026-05-15 |
| B515NCRTT475550080 | Swedge Rod, Hyper-Lordotic Curved, Transition | NCRTT47555-080 | | 2026-05-15 |
| B515NCRTT475550090 | Swedge Rod, Hyper-Lordotic Curved, Transition | NCRTT47555-090 | | 2026-05-15 |
| B515NCRTT475550100 | Swedge Rod, Hyper-Lordotic Curved, Transition | NCRTT47555-100 | | 2026-05-15 |
| B515RMCT55065 | Swedge Rod, MIS, Curved | RMCT55-65 | | 2026-05-15 |
| B515RSCT55045 | Swedge Rod | RSCT55-45 | | 2026-05-15 |
| B515RSCT55050 | Swedge Rod | RSCT55-50 | | 2026-05-15 |
| B515RSCT600500 | Swedge Rod | RSCT60-500 | | 2026-05-15 |
| B515RSCTT475550040 | Swedge Rod | RSCTT47555-040 | | 2026-05-15 |
| B515RSCTT475550045 | Swedge Rod | RSCTT47555-045 | | 2026-05-15 |
| B515RSCTT475550050 | Swedge Rod | RSCTT47555-050 | | 2026-05-15 |
| B515RSCTT475550120 | Swedge Rod | RSCTT47555-120 | | 2026-05-15 |
| B515RSCTT475550150 | Swedge Rod | RSCTT47555-150 | | 2026-05-15 |
Other Devices Sharing Product Codes#