LnK Spinal Fixation System
- Primary DI
- 08806344320512
- Brand
- LnK Spinal Fixation System
- Company
- L&K BIOMED CO. ,LTD.
- Model
- 1611-2610
- Catalog number
- 1611-2610
- Device description
- General Hook, Standard, 10mm
- Published
- 2016-08-31
- 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 | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08806344320512 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08806344320512 | 08806344320512 | 8806344320512 |
GMDN Terms
| Term | Definition |
|---|
| Bone-screw internal spinal fixation system hook | An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design 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 typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw. |
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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