LnK Posterior Cervical Fixation System
LnK transition rods are connection components within a posterior cervical-thoracic fixation system. Rods link the screw and hook anchors across the chosen spinal segments; straight and…
LnK transition rods are connection components within a posterior cervical-thoracic fixation system. Rods link the screw and hook anchors across the chosen spinal segments; straight and curved forms are also part of the range.
Rod materials include titanium alloy and cobalt-chromium alloy. Cervical screws, hooks and set screws are titanium alloy; cobalt-chromium is restricted to rods in this described system.
Listed Item
L&K Biomed Cervical Transitional Rod (Titanium) 3.5×200-5.5x100mm 1EA
Level and Component Scope
Hooks and rods support stabilization from C1 to T3. Pedicle screws are restricted to T1-T3 for thoracic conditions and are not intended for cervical placement. The top-loading system is used through an open approach, with a listed titanium transition rod representing one component choice.
11manufacturers in China registered for this device type
262catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | L&K Biomed Co., Ltd., South Korea |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K143278 |
| Record published | 2015-09-22 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6115-4034 | In distribution | |
| 6115-4018 | In distribution | |
| 6101-6036 | In distribution | |
| 6111-3530 | In distribution | |
| 6124-3512 | In distribution | |
| 6115-3510 | In distribution | |
| 6132-3560 | In distribution | |
| 6115-3518 | In distribution | |
| 1052-55210 | In distribution | |
| 6119-3524 | In distribution | |
| 6111-3538 | In distribution | |
| 6112-3514 | In distribution | |
| 6115-4014 | In distribution | |
| 6114-3518 | In distribution | |
| 6115-4026 | In distribution | |
| 6114-4014 | In distribution | |
| 6131-3540 | In distribution | |
| 6131-3560 | In distribution | |
| 6125-5520 | In distribution | |
| 6111-3542 | In distribution | |
| 6111-4010 | In distribution | |
| 6121-3520 | In distribution | |
| 6112-3530 | In distribution | |
| 6118-4040 | In distribution | |
| 6111-4046 | In distribution | |
| 6139-3535 | In distribution | |
| 6116-4026 | In distribution | |
| 6114-3510 | In distribution | |
| 6116-3518 | In distribution | |
| 6112-3542 | In distribution | |
| 6116-4034 | In distribution | |
| 6119-4024 | In distribution | |
| 6122-3504 | In distribution | |
| 6116-3530 | In distribution | |
| 6117-3540 | In distribution | |
| 6112-3526 | In distribution | |
| 6119-4040 | In distribution | |
| 6136-3550 | In distribution | |
| 6121-3507 | In distribution | |
| 6111-4014 | In distribution | |
| 1052-55270 | In distribution | |
| 6111-3522 | In distribution | |
| 1052-55230 | In distribution | |
| 6115-4010 | In distribution | |
| 6112-4018 | In distribution | |
| 6121-3516 | In distribution | |
| 6112-3518 | In distribution | |
| 6114-3550 | In distribution | |
| 6118-4028 | In distribution | |
| 6112-4014 | In distribution | |
| 6132-1805 | In distribution | |
| 6122-3517 | In distribution | |
| 6115-4050 | In distribution | |
| 6114-4022 | In distribution | |
| 6121-3524 | In distribution | |
| 6119-3520 | In distribution | |
| 1052-55430 | In distribution | |
| 6114-4038 | In distribution | |
| 6122-3504 | In distribution | |
| 6113-4048 | In distribution | |
| 6134-3580 | In distribution | |
| 6113-3534 | In distribution | |
| 6119-4028 | In distribution | |
| 6126-5520 | In distribution | |
| 6122-3513 | In distribution | |
| 6116-3510 | In distribution | |
| 6116-3546 | In distribution | |
| 6114-3546 | In distribution | |
| 6112-4050 | In distribution | |
| 6119-4020 | In distribution | |
| 6118-3532 | In distribution | |
| 6124-3508 | In distribution | |
| 6122-3515 | In distribution | |
| 6111-3510 | In distribution | |
| 6131-1806 | In distribution | |
| 6131-1604 | In distribution | |
| 6119-4036 | In distribution | |
| 6139-3550 | In distribution | |
| 6116-4010 | In distribution | |
| 6113-3526 | In distribution | |
| 6117-4036 | In distribution | |
| 6115-3546 | In distribution | |
| 6111-4022 | In distribution | |
| 6113-3538 | In distribution | |
| 6117-4020 | In distribution | |
| 6118-4032 | In distribution | |
| 1052-55410 | In distribution | |
| 6114-3522 | In distribution | |
| 6124-3514 | In distribution | |
| 6124-3524 | In distribution | |
| 6113-4036 | In distribution | |
| 6138-3565 | In distribution | |
| 6111-4030 | In distribution | |
| 6117-4024 | In distribution | |
| 6112-4026 | In distribution | |
| 6112-4010 | In distribution | |
| 6123-3513 | In distribution | |
| 1052-55330 | In distribution | |
| 1052-55370 | In distribution | |
| 6138-3550 | In distribution | |
| 6135-3580 | In distribution | |
| 1052-55390 | In distribution | |
| 6137-3550 | In distribution | |
| 6116-3526 | In distribution | |
| 6123-3515 | In distribution | |
| 6112-3550 | In distribution | |
| 6115-4046 | In distribution | |
| 6114-4034 | In distribution | |
| 6123-3519 | In distribution | |
| 6116-4042 | In distribution | |
| 6132-3540 | In distribution | |
| 6116-3542 | In distribution | |
| 6124-3510 | In distribution | |
| 6121-3505 | In distribution | |
| 6115-3530 | In distribution | |
| 6113-3530 | In distribution | |
| 6115-3534 | In distribution | |
| 6139-3565 | In distribution | |
| 6114-3542 | In distribution | |
| 6123-3522 | In distribution | |
| 6111-3550 | In distribution | |
| 6121-3512 | In distribution | |
| 6124-3504 | In distribution | |
| 6112-3522 | In distribution | |
| 6116-4046 | In distribution | |
| 6116-3522 | In distribution | |
| 6115-3538 | In distribution | |
| 6114-4042 | In distribution | |
| 6116-4014 | In distribution | |
| 6134-3560 | In distribution | |
| 6133-1906 | In distribution | |
| 6111-3534 | In distribution | |
| 6126-5625 | In distribution | |
| 6125-5425 | In distribution | |
| 6114-4018 | In distribution | |
| 6123-3509 | In distribution | |
| 6132-3580 | In distribution | |
| 6118-3524 | In distribution | |
| 6115-3550 | In distribution | |
| 6125-5625 | In distribution | |
| 6111-3514 | In distribution | |
| 6111-3518 | In distribution | |
| 6116-4022 | In distribution | |
| 6133-3560 | In distribution | |
| 6113-4028 | In distribution | |
| 1052-55195 | In distribution | |
| 6123-3517 | In distribution | |
| 6123-3505 | In distribution | |
| 6113-4024 | In distribution | |
| 6121-3510 | In distribution | |
| 6122-3522 | In distribution | |
| 6119-3532 | In distribution | |
| 1052-55310 | In distribution | |
| 6115-3522 | In distribution | |
| 6121-3514 | In distribution | |
| 6137-3565 | In distribution | |
| 6114-3514 | In distribution | |
| 6112-4038 | In distribution | |
| 6113-3522 | In distribution | |
| 6113-4016 | In distribution | |
| 6114-4046 | In distribution | |
| 6118-3540 | In distribution | |
| 6134-3545 | In distribution | |
| 6131-3580 | In distribution | |
| 6115-4030 | In distribution | |
| 6122-3506 | In distribution | |
| 6113-3550 | In distribution | |
| 6113-3514 | In distribution | |
| 6133-1704 | In distribution | |
| 6124-3520 | In distribution | |
| 6124-3518 | In distribution | |
| 6113-4020 | In distribution | |
| 6113-4040 | In distribution | |
| 6114-3538 | In distribution | |
| 1052-55185 | In distribution | |
| 6118-3528 | In distribution | |
| 6117-3532 | In distribution | |
| 6117-3536 | In distribution | |
| 6116-3534 | In distribution | |
| 6111-4042 | In distribution | |
| 6113-3518 | In distribution | |
| 6116-4038 | In distribution | |
| 6117-4032 | In distribution | |
| 6115-4038 | In distribution | |
| 6114-4030 | In distribution | |
| 6123-3507 | In distribution | |
| 6117-4040 | In distribution | |
| 6122-3509 | In distribution | |
| 6118-4024 | In distribution | |
| 6118-3536 | In distribution | |
| 6115-4042 | In distribution | |
| 6116-3550 | In distribution | |
| 6114-3530 | In distribution | |
| 6121-3506 | In distribution | |
| 6112-4030 | In distribution | |
| 6133-3580 | In distribution | |
| 6118-3520 | In distribution | |
| 6135-3545 | In distribution | |
| 6112-4042 | In distribution | |
| 6113-3546 | In distribution | |
| 6116-3514 | In distribution | |
| 6116-4050 | In distribution | |
| 6111-4038 | In distribution | |
| 6113-4032 | In distribution | |
| 6113-3542 | In distribution | |
| 6115-3542 | In distribution | |
| 6121-3518 | In distribution | |
| 6112-4022 | In distribution | |
| 6122-3511 | In distribution | |
| 6116-4030 | In distribution | |
| 6111-3526 | In distribution | |
| 6119-3528 | In distribution | |
| 1052-55290 | In distribution | |
| 6115-3514 | In distribution | |
| 1052-55350 | In distribution | |
| 6119-3536 | In distribution | |
| 6137-3535 | In distribution | |
| 6113-3510 | In distribution | |
| 6117-3528 | In distribution | |
| 6116-4018 | In distribution | |
| 6136-3565 | In distribution | |
| 6118-4036 | In distribution | |
| 6122-3506 | In distribution | |
| 6122-3519 | In distribution | |
| 6117-4028 | In distribution | |
| 6115-4022 | In distribution | |
| 6119-4032 | In distribution | |
| 6115-3526 | In distribution | |
| 6111-3546 | In distribution | |
| 6103-7037 | In distribution | |
| 6116-3538 | In distribution | |
| 6138-3535 | In distribution | |
| 6111-4050 | In distribution | |
| 6121-3508 | In distribution | |
| 6117-3524 | In distribution | |
| 6111-4018 | In distribution | |
| 6114-4050 | In distribution | |
| 6123-3511 | In distribution | |
| 6111-4026 | In distribution | |
| 6133-3540 | In distribution | |
| 6112-3538 | In distribution | |
| 6112-3534 | In distribution | |
| 6112-4034 | In distribution | |
| 6135-3560 | In distribution | |
| 6126-5425 | In distribution | |
| 6111-4034 | In distribution | |
| 6113-4044 | In distribution | |
| 6124-3506 | In distribution | |
| 6124-3516 | In distribution | |
| 6118-4020 | In distribution |
Showing 250 of 262 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143278 | 2015-07-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.