OpenLoc-L Spinal Fixation System
Poly Lateral Closed Connector Curved Anodized (L1: 57, L2: 40)
11manufacturers in China registered for this device type
396catalogue 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 |
| Record published | 2017-08-09 |
| 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 |
|---|---|---|
| 1333-6040 | In distribution | |
| 1333-85110 | In distribution | |
| 1333-6555 | In distribution | |
| 1354-85150 | In distribution | |
| 1844-6262 | In distribution | |
| 1333-4525 | In distribution | |
| 1333-65120 | In distribution | |
| 1313-7545 | In distribution | |
| 1333-70145 | In distribution | |
| 1313-7525 | In distribution | |
| 1313-8545 | In distribution | |
| 1354-6545 | In distribution | |
| 1333-65130 | In distribution | |
| 1333-6060 | In distribution | |
| 1334-5550 | In distribution | |
| 1314-7575 | In distribution | |
| 1314-70100 | In distribution | |
| 1334-4560 | In distribution | |
| 1910-6340 | In distribution | |
| 1908-6040 | In distribution | |
| 1313-7045 | In distribution | |
| 1314-75145 | In distribution | |
| 1313-7055 | In distribution | |
| 1313-8595 | In distribution | |
| 1314-7555 | In distribution | |
| 1314-7090 | In distribution | |
| 1313-5535 | In distribution | |
| 1314-6545 | In distribution | |
| 1910-6350 | In distribution | |
| 1313-80110 | In distribution | |
| 1333-7045 | In distribution | |
| 1313-8555 | In distribution | |
| 1314-6555 | In distribution | |
| 1313-75125 | In distribution | |
| 1334-65110 | In distribution | |
| 1334-4045 | In distribution | |
| 1314-4040 | In distribution | |
| 1908-6140 | In distribution | |
| 1333-8095 | In distribution | |
| 1333-80145 | In distribution | |
| 1334-5530 | In distribution | |
| 1313-8060 | In distribution | |
| 1354-6595 | In distribution | |
| 1314-8040 | In distribution | |
| 1333-7085 | In distribution | |
| 1314-85135 | In distribution | |
| 1313-6020 | In distribution | |
| 1314-8060 | In distribution | |
| 1334-6530 | In distribution | |
| 1334-5560 | In distribution | |
| 1314-70140 | In distribution | |
| 1334-6540 | In distribution | |
| 1354-6020 | In distribution | |
| 1333-6575 | In distribution | |
| 1333-6535 | In distribution | |
| 1313-8565 | In distribution | |
| 1314-85145 | In distribution | |
| 1313-4035 | In distribution | |
| 1314-5545 | In distribution | |
| 1354-7080 | In distribution | |
| 1314-80110 | In distribution | |
| 1334-4520 | In distribution | |
| 1334-6520 | In distribution | |
| 1313-70150 | In distribution | |
| 1334-7055 | In distribution | |
| 1908-6130 | In distribution | |
| 1354-8560 | In distribution | |
| 1314-5040 | In distribution | |
| 1314-7525 | In distribution | |
| 1314-7030 | In distribution | |
| 1333-7550 | In distribution | |
| 1314-5030 | In distribution | |
| 1313-8050 | In distribution | |
| 1314-4020 | In distribution | |
| 1333-85100 | In distribution | |
| 1313-4520 | In distribution | |
| 1333-5525 | In distribution | |
| 1313-5525 | In distribution | |
| 1313-7035 | In distribution | |
| 1333-75140 | In distribution | |
| 1354-65125 | In distribution | |
| 1314-6535 | In distribution | |
| 1354-70120 | In distribution | |
| 1333-4050 | In distribution | |
| 1333-70135 | In distribution | |
| 1334-6570 | In distribution | |
| 1314-6030 | In distribution | |
| 1314-8030 | In distribution | |
| 1333-65105 | In distribution | |
| 1313-4540 | In distribution | |
| 1313-85145 | In distribution | |
| 1313-80130 | In distribution | |
| 1313-5030 | In distribution | |
| 1313-6520 | In distribution | |
| 1908-6150 | In distribution | |
| 1333-8050 | In distribution | |
| 1333-5545 | In distribution | |
| 1333-8550 | In distribution | |
| 1313-75145 | In distribution | |
| 1314-6525 | In distribution | |
| 1333-80125 | In distribution | |
| 1333-8075 | In distribution | |
| 1354-5050 | In distribution | |
| 1314-8020 | In distribution | |
| 1314-7070 | In distribution | |
| 1354-7545 | In distribution | |
| 1313-5555 | In distribution | |
| 1314-7080 | In distribution | |
| 1333-7570 | In distribution | |
| 1314-70130 | In distribution | |
| 1314-8070 | In distribution | |
| 1333-8580 | In distribution | |
| 1314-85125 | In distribution | |
| 1333-5030 | In distribution | |
| 1333-8060 | In distribution | |
| 1314-4050 | In distribution | |
| 1354-65145 | In distribution | |
| 1334-6055 | In distribution | |
| 1333-8520 | In distribution | |
| 1314-7565 | In distribution | |
| 1313-5050 | In distribution | |
| 1313-65140 | In distribution | |
| 1314-8565 | In distribution | |
| 1334-6590 | In distribution | |
| 1333-6020 | In distribution | |
| 1354-5035 | In distribution | |
| 1314-65115 | In distribution | |
| 1354-7070 | In distribution | |
| 1314-75135 | In distribution | |
| 1354-85140 | In distribution | |
| 1354-70130 | In distribution | |
| 1908-6320 | In distribution | |
| 1354-6030 | In distribution | |
| 1333-5535 | In distribution | |
| 1334-7025 | In distribution | |
| 1314-65135 | In distribution | |
| 1334-5055 | In distribution | |
| 1354-70140 | In distribution | |
| 1313-8585 | In distribution | |
| 1333-70115 | In distribution | |
| 1334-5025 | In distribution | |
| 1901-6650 | In distribution | |
| 1354-6040 | In distribution | |
| 1314-7050 | In distribution | |
| 1333-6050 | In distribution | |
| 1334-4540 | In distribution | |
| 1354-70110 | In distribution | |
| 1333-7540 | In distribution | |
| 1333-8085 | In distribution | |
| 1333-5020 | In distribution | |
| 1333-5060 | In distribution | |
| 1314-65105 | In distribution | |
| 1333-65115 | In distribution | |
| 1313-4530 | In distribution | |
| 1333-70125 | In distribution | |
| 1333-80135 | In distribution | |
| 1314-5555 | In distribution | |
| 1354-6050 | In distribution | |
| 1910-6320 | In distribution | |
| 1354-4045 | In distribution | |
| 1334-65130 | In distribution | |
| 1313-70130 | In distribution | |
| 1333-80115 | In distribution | |
| 1314-7535 | In distribution | |
| 1354-85130 | In distribution | |
| 1313-7025 | In distribution | |
| 1901-6330 | In distribution | |
| 1334-4025 | In distribution | |
| 1333-6525 | In distribution | |
| 1354-85120 | In distribution | |
| 1313-7565 | In distribution | |
| 1908-6350 | In distribution | |
| 1313-6570 | In distribution | |
| 1314-7585 | In distribution | |
| 1314-65145 | In distribution | |
| 1313-75105 | In distribution | |
| 1314-85105 | In distribution | |
| 1313-7585 | In distribution | |
| 1354-4530 | In distribution | |
| 1333-4545 | In distribution | |
| 1333-7055 | In distribution | |
| 1334-7045 | In distribution | |
| 1354-4055 | In distribution | |
| 1313-75115 | In distribution | |
| 1333-70105 | In distribution | |
| 1908-6050 | In distribution | |
| 1313-6055 | In distribution | |
| 1314-4555 | In distribution | |
| 1354-4520 | In distribution | |
| 1313-6560 | In distribution | |
| 1334-4550 | In distribution | |
| 1354-65115 | In distribution | |
| 1901-6315 | In distribution | |
| 1333-5555 | In distribution | |
| 1313-7060 | In distribution | |
| 1333-6545 | In distribution | |
| 1314-5050 | In distribution | |
| 1314-80140 | In distribution | |
| 1314-6565 | In distribution | |
| 1908-6030 | In distribution | |
| 1313-6590 | In distribution | |
| 1314-6595 | In distribution | |
| 1314-4030 | In distribution | |
| 1334-6560 | In distribution | |
| 1314-65125 | In distribution | |
| 1313-85135 | In distribution | |
| 1354-6525 | In distribution | |
| 1313-70140 | In distribution | |
| 1313-8575 | In distribution | |
| 1334-6025 | In distribution | |
| 1314-70150 | In distribution | |
| 1333-75145 | In distribution | |
| 1840-6262 | In distribution | |
| 1354-4540 | In distribution | |
| 1314-4535 | In distribution | |
| 1313-75135 | In distribution | |
| 1314-6575 | In distribution | |
| 1333-7520 | In distribution | |
| 1314-8555 | In distribution | |
| 1314-8545 | In distribution | |
| 1333-8040 | In distribution | |
| 1313-85125 | In distribution | |
| 1314-6050 | In distribution | |
| 1313-8090 | In distribution | |
| 1901-6630 | In distribution | |
| 1333-75130 | In distribution | |
| 1354-7040 | In distribution | |
| 1901-6620 | In distribution | |
| 1313-8080 | In distribution | |
| 1901-6640 | In distribution | |
| 1314-6020 | In distribution | |
| 1333-85130 | In distribution | |
| 1313-5545 | In distribution | |
| 1333-8540 | In distribution | |
| 1354-65105 | In distribution | |
| 1334-65120 | In distribution | |
| 1908-6120 | In distribution | |
| 1313-85105 | In distribution | |
| 1333-8570 | In distribution | |
| 1354-5545 | In distribution | |
| 1908-6330 | In distribution | |
| 1313-6580 | In distribution | |
| 1333-7075 | In distribution | |
| 1354-5555 | In distribution | |
| 1314-8535 | In distribution | |
| 1314-6060 | In distribution | |
| 1333-8030 | In distribution | |
| 1313-65100 | In distribution | |
| 1333-8530 | In distribution | |
| 1314-4545 | In distribution |
Showing 250 of 300 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.