SureLOK MIS 3l
CL Percutaneous Straight Ti Rod, 5.5mm x 100mm
13manufacturers in China registered for this device type
69catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Precision Spine, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K141397 |
| Record published | 2019-04-09 |
| Record revised | 2025-11-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 63-ST-5100 | In distribution | |
| 63-LT-5130 | In distribution | |
| 63-CP-5535 | In distribution | |
| 63-ST-5065 | In distribution | |
| 63-LT-5050 | In distribution | |
| 63-8200 | In distribution | |
| 63-LT-5100 | In distribution | |
| 63-ST-5160 | In distribution | |
| 63-ST-5180 | In distribution | |
| 63-CP-7550 | In distribution | |
| 63-LT-5080 | In distribution | |
| 63-CP-8545 | In distribution | |
| 63-ST-5080 | In distribution | |
| 63-LT-5110 | In distribution | |
| 63-ST-5035 | In distribution | |
| 63-CP-5540 | In distribution | |
| 63-ST-5055 | In distribution | |
| 63-LT-5075 | In distribution | |
| 63-CP-8530 | In distribution | |
| 63-ST-5130 | In distribution | |
| 63-CP-6550 | In distribution | |
| 63-ST-5600 | In distribution | |
| 63-CP-5525 | In distribution | |
| 63-ST-5150 | In distribution | |
| 63-CP-6555 | In distribution | |
| 63-CP-8560 | In distribution | |
| 63-ST-5070 | In distribution | |
| 63-CP-5545 | In distribution | |
| 63-CP-6545 | In distribution | |
| 63-ST-5170 | In distribution | |
| 63-ST-5200 | In distribution | |
| 63-CP-8570 | In distribution | |
| 63-ST-5190 | In distribution | |
| 63-ST-5075 | In distribution | |
| 63-ST-5300 | In distribution | |
| 63-CP-8540 | In distribution | |
| 63-CP-6560 | In distribution | |
| 63-CP-8555 | In distribution | |
| 63-LT-5045 | In distribution | |
| 63-ST-5400 | In distribution | |
| 63-CP-5530 | In distribution | |
| 63-CP-7560 | In distribution | |
| 63-LT-5140 | In distribution | |
| 63-CP-8535 | In distribution | |
| 63-LT-5055 | In distribution | |
| 63-CP-8590 | In distribution | |
| 63-ST-5060 | In distribution | |
| 63-CP-7555 | In distribution | |
| 63-CP-8580 | In distribution | |
| 63-LT-5065 | In distribution | |
| 63-ST-5045 | In distribution | |
| 63-CP-7545 | In distribution | |
| 63-LT-5090 | In distribution | |
| 63-ST-5140 | In distribution | |
| 63-LT-5040 | In distribution | |
| 63-8700-CA-01 | In distribution | |
| 63-CP-6530 | In distribution | |
| 63-CP-7530 | In distribution | |
| 63-ST-5110 | In distribution | |
| 63-CP-5555 | In distribution | |
| 63-CP-8525 | In distribution | |
| 63-LT-5150 | In distribution | |
| 63-CP-7540 | In distribution | |
| 63-ST-5500 | In distribution | |
| 63-CP-5550 | In distribution | |
| 63-ST-5090 | In distribution | |
| 63-LT-5070 | In distribution | |
| 63-LT-5035 | In distribution | |
| 63-ST-5050 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141397 | 2014-06-26 |
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.