Sterile Spine Pedicle Screw System
- Primary DI
- B562066366BWB0
- Brand
- Sterile Spine Pedicle Screw System
- Company
- WISHBONE MEDICAL, INC.
- Model
- 06.6366B-WB
- Device description
- Ø5.5 Polyaxial Pedicle Screw, Non-Cannulated Ø5.5 X 55mm (Blue)
- Published
- 2020-12-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B562066366BWB0 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Spinal bone screw, non-bioabsorbable | A small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 062355158
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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