SureLOK Mini Posterior Cervical/Upper Thoracic System
Smooth Shank Screw Sterilization Case - Empty
11manufacturers in China registered for this device type
94catalogue 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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Manufacturer |
| 510(k) | K150851 |
| Record published | 2019-04-10 |
| Record revised | 2025-11-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04-SB-4032 | In distribution | |
| 04-0070 | In distribution | |
| 04-1016-35 | In distribution | |
| 04-1016-62 | In distribution | |
| 04-3530 | In distribution | |
| 04-0040 | In distribution | |
| 04-4008 | In distribution | |
| 04-0020 | In distribution | |
| 04-SB-4038 | In distribution | |
| 04-SB-4036 | In distribution | |
| 04-0120T | In distribution | |
| 04-3516 | In distribution | |
| 04-3512 | In distribution | |
| 04-3508 | In distribution | |
| 04-1013-14 | In distribution | |
| 04-BK-0101 | In distribution | |
| 04-SB-3538 | In distribution | |
| 04-SC-0101 | In distribution | |
| 50-0005 | In distribution | |
| 04-SB-4028 | In distribution | |
| 04-1017-05 | In distribution | |
| 04-0240T | In distribution | |
| 04-SB-4040 | In distribution | |
| 04-4012 | In distribution | |
| 04-1015-00 | In distribution | |
| 04-1014-25 | In distribution | |
| 04-1015-45 | In distribution | |
| 04-4030 | In distribution | |
| 04-9202 | In distribution | |
| 04-0090 | In distribution | |
| 04-9201 | In distribution | |
| 04-4016 | In distribution | |
| 04-1016-55 | In distribution | |
| 04-4040 | In distribution | |
| 04-0080T | In distribution | |
| 04-SB-4034 | In distribution | |
| 04-SB-3536 | In distribution | |
| 04-4018 | In distribution | |
| 04-SB-3522 | In distribution | |
| 04-06ROH | In distribution | |
| 04-SB-3540 | In distribution | |
| 04-1017-30 | In distribution | |
| 04-1000 | In distribution | |
| 04-SB-3532 | In distribution | |
| 04-0080 | In distribution | |
| 04-4025 | In distribution | |
| 04-0240 | In distribution | |
| 04-SB-3524 | In distribution | |
| 04-1015-35 | In distribution | |
| 50-0006 | In distribution | |
| 04-05ROH | In distribution | |
| 04-4010 | In distribution | |
| 04-0120 | In distribution | |
| 04-SB-4026 | In distribution | |
| 04-4020 | In distribution | |
| 04-SB-3530 | In distribution | |
| 04-0100 | In distribution | |
| 04-1015-55 | In distribution | |
| 04-9201-CA | In distribution | |
| 04-3520 | In distribution | |
| 04-SB-3526 | In distribution | |
| 04-4014 | In distribution | |
| 04-3525 | In distribution | |
| 04-0060T | In distribution | |
| 04-3535 | In distribution | |
| 04-3510 | In distribution | |
| 04-05STH | In distribution | |
| 04-9202-CA | In distribution | |
| 04-SB-3528 | In distribution | |
| 04-SB-3520 | In distribution | |
| 04-3518 | In distribution | |
| 04-SB-4030 | In distribution | |
| 04-1014-14 | In distribution | |
| 04-1017-45 | In distribution | |
| 04-0060 | In distribution | |
| 04-06LOH | In distribution | |
| 04-SC-0103 | In distribution | |
| 04-1016-45 | In distribution | |
| 04-SB-4024 | In distribution | |
| 04-SB-4022 | In distribution | |
| 04-1017-35 | In distribution | |
| 04-SB-3534 | In distribution | |
| 04-05LOH | In distribution | |
| 04-0500T | In distribution | |
| 04-SB-4020 | In distribution | |
| 04-1015-62 | In distribution | |
| 04-0050 | In distribution | |
| 04-3540 | In distribution | |
| 04-1013-25 | In distribution | |
| 04-0030 | In distribution | |
| 04-3514 | In distribution | |
| 04-06STH | In distribution | |
| 04-SC-0102 | In distribution | |
| 04-4035 | In distribution |
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 |
|---|---|
| K150851 | 2015-06-04 |
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.