OpenLoc-L Spinal Fixation System/LnK Spinal Fixation System
- Primary DI
- 08806344361867
- Brand
- OpenLoc-L Spinal Fixation System/LnK Spinal Fixation System
- Company
- L&K BIOMED CO. ,LTD.
- Model
- 1306-0000
- Catalog number
- 1306-0000
- Device description
- Star Type (Closed Type with Rescue Hole)
- Published
- 2017-09-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
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 |
|---|
| 08806344361867 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08806344361867 | 08806344361867 | 8806344361867 |
GMDN Terms
| Term | Definition |
|---|
| Spinal bone set screw | A small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw (screw head), anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy). |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 631159324
- 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
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