LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System
- Primary DI
- 08800061699814
- Brand
- LnK Spinal Fixation System/ OpenLoc-L Spinal Fixation System
- Company
- L&K BIOMED CO. ,LTD.
- Model
- 1280-60400S
- Catalog number
- 1280-60400S
- Device description
- S rod
- Published
- 2023-07-11
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- 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 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K231636 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800061699814 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08800061699814 | 08800061699814 | 8800061699814 |
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 |
|---|
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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
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|---|---|---|---|---|
| 08809986488718 | CastleLoc Pectus Bar System Instrument Set | PB02-0001 | 2026-03-09 | |
| 08809986488725 | CastleLoc Pectus Bar System Instrument Set | PB01-0070 | 2026-03-09 | |
| 08809986488732 | CastleLoc Pectus Bar System Instrument Set | PB01-0003S | 2026-03-09 | |
| 08809986488749 | CastleLoc Pectus Bar System Instrument Set | PB01-0802 | 2026-03-09 | |
| 08809986488756 | CastleLoc Pectus Bar System Instrument Set | PB01-1002 | 2026-03-09 | |
| 08809986488763 | CastleLoc Pectus Bar System Instrument Set | PB01-1202 | 2026-03-09 | |
| 08809986488770 | CastleLoc Pectus Bar System Instrument Set | PB01-1402 | 2026-03-09 | |
| 08809986488787 | CastleLoc Pectus Bar System Instrument Set | PB01-1602 | 2026-03-09 | |
| 08809986488794 | CastleLoc Pectus Bar System Instrument Set | PB01-0069L | 2026-03-09 | |
| 08809986488800 | CastleLoc Pectus Bar System Instrument Set | PB01-0001S | 2026-03-09 | |
| 08809986488817 | CastleLoc Pectus Bar System Instrument Set | PB01-0001M | 2026-03-09 | |
| 08809986488824 | CastleLoc Pectus Bar System Instrument Set | PB01-0001L | 2026-03-09 | |
| 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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|---|---|---|---|---|
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| 00840185382573 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382580 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382597 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 07290014381254 | ProMIS™ Fixation System | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 07290014381261 | ProMIS™ Fixation System | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 07290115935615 | Counter Torque ST | PREMIA SPINE LTD | NKB | 2026-05-25 |
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| 06941312465559 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
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| 06941312465573 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465580 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465597 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465603 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465610 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465627 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
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