Lospa IS Spinal Fixation System
CANNULATED POLYAXIAL GUIDED PEDICLE SCREW - Guided type Ø6.5 X 50, Length27.5mm
14manufacturers in China registered for this device type
777catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Corentec Co., Ltd., South Korea |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K200267 |
| Record published | 2020-03-21 |
| 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 |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA.223.8550 | In distribution | |
| SA.228.6540 | In distribution | |
| 01.71.023 | In distribution | |
| SA.223.4520 | In distribution | |
| SA.226.9570 | In distribution | |
| SA.226.8580 | In distribution | |
| SA.M60.0250 | In distribution | |
| SI.0P1.0028 | In distribution | |
| SA.221.5025 | In distribution | |
| SA.227.6570 | In distribution | |
| SA.221.6590 | In distribution | |
| SA.228.9511 | In distribution | |
| SI.MP6.0009 | In distribution | |
| SI.AP6.9103 | In distribution | |
| SA.226.6010 | In distribution | |
| SA.228.6090 | In distribution | |
| SA.223.4020 | In distribution | |
| SA.226.6550 | In distribution | |
| SA.228.7580 | In distribution | |
| SA.227.9515 | In distribution | |
| SA.227.8035 | In distribution | |
| SA.225.6010 | In distribution | |
| SA.223.8580 | In distribution | |
| SA.227.8585 | In distribution | |
| 01.71.016 | In distribution | |
| SA.227.7095 | In distribution | |
| SA.223.8513 | In distribution | |
| SA.226.9515 | In distribution | |
| SA.226.5530 | In distribution | |
| SA.221.8530 | In distribution | |
| SI.MP6.0008 | In distribution | |
| SA.223.6045 | In distribution | |
| SA.221.7575 | In distribution | |
| SI.0P1.0016 | In distribution | |
| SA.228.7565 | In distribution | |
| SA.228.8535 | In distribution | |
| SA.222.8011 | In distribution | |
| SA.228.8512 | In distribution | |
| SA.607.6550 | In distribution | |
| SA.M55.0350 | In distribution | |
| 01.71.034 | In distribution | |
| SA.227.7540 | In distribution | |
| SI.AP6.0043 | In distribution | |
| SA.227.4535 | In distribution | |
| SA.227.7080 | In distribution | |
| SA.607.6555 | In distribution | |
| SA.M55.0040 | In distribution | |
| SA.226.7040 | In distribution | |
| SA.228.8030 | In distribution | |
| SA.226.6085 | In distribution | |
| SA.221.7545 | In distribution | |
| SA.221.7050 | In distribution | |
| SA.223.5050 | In distribution | |
| SA.225.7095 | In distribution | |
| SA.228.9560 | In distribution | |
| SA.226.6530 | In distribution | |
| SA.226.7055 | In distribution | |
| G412760 | In distribution | |
| SA.228.4035 | In distribution | |
| SI.0P1.0005 | In distribution | |
| SA.221.8518 | In distribution | |
| SA.225.7570 | In distribution | |
| SA.M55.0090 | In distribution | |
| SA.221.8045 | In distribution | |
| SA.223.8514 | In distribution | |
| SA.221.6070 | In distribution | |
| SA.227.7555 | In distribution | |
| SA.223.8560 | In distribution | |
| SA.227.8565 | In distribution | |
| SA.228.8517 | In distribution | |
| SA.220.7040 | In distribution | |
| SA.226.5045 | In distribution | |
| SA.227.8570 | In distribution | |
| SA.226.7575 | In distribution | |
| SA.226.5040 | In distribution | |
| SA.608.5535 | In distribution | |
| SA.M55.0060 | In distribution | |
| 01.71.041 | In distribution | |
| SA.223.6065 | In distribution | |
| SI.0P1.0021 | In distribution | |
| SA.228.8011 | In distribution | |
| SI.0P0.0009 | In distribution | |
| SA.228.6580 | In distribution | |
| SA.606.7550 | In distribution | |
| SA.605.6545 | In distribution | |
| SA.221.7070 | In distribution | |
| SA.226.8040 | In distribution | |
| SA.226.7070 | In distribution | |
| SA.226.8516 | In distribution | |
| SA.606.7545 | In distribution | |
| SA.225.9512 | In distribution | |
| SA.226.7580 | In distribution | |
| SA.227.4055 | In distribution | |
| SA.226.7511 | In distribution | |
| SA.226.7590 | In distribution | |
| SA.607.7530 | In distribution | |
| SA.226.7060 | In distribution | |
| SA.223.6070 | In distribution | |
| SA.M60.0065 | In distribution | |
| SA.226.8517 | In distribution | |
| SA.226.8095 | In distribution | |
| SA.228.9565 | In distribution | |
| SA.228.7045 | In distribution | |
| SP.C52.0035 | In distribution | |
| SA.228.5550 | In distribution | |
| SA.605.5540 | In distribution | |
| SA.227.9511 | In distribution | |
| SA.M55.0250 | In distribution | |
| SA.226.8018 | In distribution | |
| SA.227.4545 | In distribution | |
| SA.226.8515 | In distribution | |
| SI.0P0.0001 | In distribution | |
| SA.225.7585 | In distribution | |
| SA.228.5040 | In distribution | |
| SA.225.7550 | In distribution | |
| SA.M55.0070 | In distribution | |
| SI.MP6.0007 | In distribution | |
| SA.227.8050 | In distribution | |
| SA.228.6080 | In distribution | |
| SA.223.6535 | In distribution | |
| 01.71.024 | In distribution | |
| 91200100 | In distribution | |
| SA.222.8555 | In distribution | |
| SA.226.9518 | In distribution | |
| SA.223.7575 | In distribution | |
| SA.605.7535 | In distribution | |
| SA.226.8585 | In distribution | |
| SA.221.4530 | In distribution | |
| SA.226.8065 | In distribution | |
| SA.227.8530 | In distribution | |
| SA.228.8516 | In distribution | |
| SA.608.5525 | In distribution | |
| SA.221.5555 | In distribution | |
| SA.226.7090 | In distribution | |
| SA.228.7060 | In distribution | |
| SA.228.6070 | In distribution | |
| SA.226.8080 | In distribution | |
| SA.223.7570 | In distribution | |
| SA.228.7514 | In distribution | |
| SI.AP6.0029 | In distribution | |
| SA.228.7055 | In distribution | |
| SA.222.6585 | In distribution | |
| SA.221.6075 | In distribution | |
| 23000100 | In distribution | |
| SA.226.9511 | In distribution | |
| SA.M55.0200 | In distribution | |
| SA.226.9560 | In distribution | |
| SI.AP6.0024 | In distribution | |
| SA.226.6525 | In distribution | |
| SA.226.6065 | In distribution | |
| SA.M60.0075 | In distribution | |
| SA.606.6535 | In distribution | |
| 23000201 | In distribution | |
| SA.M55.0180 | In distribution | |
| SA.607.6525 | In distribution | |
| SA.221.7510 | In distribution | |
| SI.AP6.0006 | In distribution | |
| SA.227.8575 | In distribution | |
| SA.220.7516 | In distribution | |
| SA.607.7550 | In distribution | |
| 23001900 | In distribution | |
| SA.220.7590 | In distribution | |
| SA.221.7595 | In distribution | |
| SA.226.8510 | In distribution | |
| SA.228.6530 | In distribution | |
| SA.228.9530 | In distribution | |
| 800-048 | In distribution | |
| SA.226.4555 | In distribution | |
| SA.226.8011 | In distribution | |
| 01.71.057 | In distribution | |
| G113974 | In distribution | |
| SA.221.8560 | In distribution | |
| SA.222.4535 | In distribution | |
| SA.223.7014 | In distribution | |
| SA.228.4050 | In distribution | |
| SA.606.5530 | In distribution | |
| SA.226.8514 | In distribution | |
| SA.228.7095 | In distribution | |
| SA.227.6540 | In distribution | |
| SA.220.6550 | In distribution | |
| SA.227.6045 | In distribution | |
| SA.228.6560 | In distribution | |
| SA.226.6045 | In distribution | |
| SA.228.7515 | In distribution | |
| SA.606.6560 | In distribution | |
| SA.225.6585 | In distribution | |
| SA.226.7010 | In distribution | |
| SA.227.9513 | In distribution | |
| SA.226.7065 | In distribution | |
| SA.221.6095 | In distribution | |
| SA.223.5545 | In distribution | |
| SA.221.6555 | In distribution | |
| SA.228.7511 | In distribution | |
| SA.226.9550 | In distribution | |
| SA.223.6040 | In distribution | |
| SI.0P1.0024 | In distribution | |
| SA.228.7550 | In distribution | |
| SA.228.9514 | In distribution | |
| SA.607.7535 | In distribution | |
| SA.223.8013 | In distribution | |
| SA.226.6090 | In distribution | |
| SA.228.9585 | In distribution | |
| SA.226.7545 | In distribution | |
| SA.223.6010 | In distribution | |
| SA.228.6065 | In distribution | |
| SA.223.7517 | In distribution | |
| SA.223.8530 | In distribution | |
| SA.228.7025 | In distribution | |
| SA.220.6595 | In distribution | |
| SA.228.4540 | In distribution | |
| SA.226.9535 | In distribution | |
| 01.71.051 | In distribution | |
| SA.M55.0110 | In distribution | |
| SA.222.8595 | In distribution | |
| SA.220.7013 | In distribution | |
| SA.223.7516 | In distribution | |
| SA.225.9535 | In distribution | |
| SA.223.7095 | In distribution | |
| SA.228.8070 | In distribution | |
| SA.223.6540 | In distribution | |
| SA.228.6510 | In distribution | |
| SA.222.7535 | In distribution | |
| 20203302 | In distribution | |
| SA.221.8013 | In distribution | |
| SP.C52.0028 | In distribution | |
| SA.608.7525 | In distribution | |
| SA.608.6540 | In distribution | |
| 01.71.013 | In distribution | |
| SA.228.5555 | In distribution | |
| SA.227.9595 | In distribution | |
| 01.71.033 | In distribution | |
| SA.226.9540 | In distribution | |
| SA.223.7040 | In distribution | |
| SA.607.5545 | In distribution | |
| SA.608.7535 | In distribution | |
| SA.605.7530 | In distribution | |
| SA.223.7560 | In distribution | |
| SA.226.9565 | In distribution | |
| SA.228.5025 | In distribution | |
| SA.226.7570 | In distribution | |
| SA.608.6560 | In distribution | |
| SI.ZH1.0003 | In distribution | |
| SA.220.7510 | In distribution | |
| SA.221.6030 | In distribution | |
| SA.608.7555 | In distribution | |
| SA.223.4045 | In distribution | |
| SA.228.8040 | In distribution | |
| SA.M55.0190 | In distribution | |
| SA.605.7555 | In distribution | |
| SA.221.8515 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161641 | 2017-01-05 |
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.