LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System
- Primary DI
- 08800061699333
- Brand
- LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System
- Company
- L&K BIOMED CO. ,LTD.
- Model
- 1280-50400
- Catalog number
- 1280-50400
- Device description
- S rod
- Published
- 2023-07-10
- Public version status
- New
- 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 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K231636 | 000 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | L&K BIOMED Co., Ltd. | 2023-06-27 | NKB |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08800061699333 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08800061699333 | 08800061699333 | 8800061699333 |
GMDN Terms
| Term | Definition |
|---|
| Bone-screw internal spinal fixation system, sterile | An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included. |
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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|---|
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| 08809986488831 | CastleLoc Pectus Bar System Instrument Set | PB01-0002S | | 2026-03-09 |
| 08809986488848 | CastleLoc Pectus Bar System Instrument Set | PB01-0002M | | 2026-03-09 |
| 08809986488855 | CastleLoc Pectus Bar System Instrument Set | PB01-0002L | | 2026-03-09 |
| 08809986488862 | CastleLoc Pectus Bar System Instrument Set | PB02-0001S | | 2026-03-09 |
| 08809986488879 | CastleLoc Pectus Bar System Instrument Set | PB02-0001M | | 2026-03-09 |
| 08809986488886 | CastleLoc Pectus Bar System Instrument Set | PB02-0001L | | 2026-03-09 |
| 08809986488893 | CastleLoc Pectus Bar System Instrument Set | PB02-0002S | | 2026-03-09 |
| 08809986488909 | CastleLoc Pectus Bar System Instrument Set | PB02-0002M | | 2026-03-09 |
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