Lospa IS Spinal System
Rod-140mm(ø6mm Titanium Rod Pre Bent - Standard Flat end)
13manufacturers in China registered for this device type
273catalogue numbers in this listing
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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Corentec Co., Ltd., South Korea |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K132644 |
| Record published | 2015-10-21 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA.R55.0450 | In distribution | |
| 01.28.466 | In distribution | |
| SA.000.4525 | In distribution | |
| 01.21.041 | In distribution | |
| SA.002.8535 | In distribution | |
| SA.R17.0090 | In distribution | |
| SA.R55.0130 | In distribution | |
| SA.006.7525 | In distribution | |
| SA.003.7525 | In distribution | |
| SA.005.7525 | In distribution | |
| SA.002.5525 | In distribution | |
| SA.002.7535 | In distribution | |
| 01.29.668 | In distribution | |
| SA.001.7535 | In distribution | |
| 01.22.938 | In distribution | |
| 01.28.565 | In distribution | |
| SA.002.5545 | In distribution | |
| 01.28.468 | In distribution | |
| 01.21.082 | In distribution | |
| 01.29.662 | In distribution | |
| 01.21.035 | In distribution | |
| 01.29.468 | In distribution | |
| 01.21.037 | In distribution | |
| SA.000.5535 | In distribution | |
| SA.001.5535 | In distribution | |
| SA.003.6530 | In distribution | |
| SA.000.8045 | In distribution | |
| SA.005.4550 | In distribution | |
| 01.29.462 | In distribution | |
| SA.001.8555 | In distribution | |
| SA.R13.0035 | In distribution | |
| SA.006.7545 | In distribution | |
| 01.21.031 | In distribution | |
| SA.006.6540 | In distribution | |
| 01.28.666 | In distribution | |
| SA.001.8045 | In distribution | |
| SA.007.4540 | In distribution | |
| SA.R13.0125 | In distribution | |
| SA.008.4530 | In distribution | |
| SA.R17.0040 | In distribution | |
| SA.003.4535 | In distribution | |
| 01.28.765 | In distribution | |
| SA.002.4555 | In distribution | |
| 01.28.767 | In distribution | |
| SA.000.7525 | In distribution | |
| SA.R12.0150 | In distribution | |
| SA.001.4025 | In distribution | |
| SA.001.8545 | In distribution | |
| 01.21.033 | In distribution | |
| SA.000.8555 | In distribution | |
| SA.007.7535 | In distribution | |
| SA.007.7525 | In distribution | |
| SA.R17.0030 | In distribution | |
| 01.28.567 | In distribution | |
| SA.003.4545 | In distribution | |
| SA.R12.0110 | In distribution | |
| SA.001.6540 | In distribution | |
| SA.R55.0150 | In distribution | |
| SA.006.5535 | In distribution | |
| SA.R13.0055 | In distribution | |
| SA.R16.0035 | In distribution | |
| SA.002.5535 | In distribution | |
| SA.R12.0030 | In distribution | |
| 01.21.080 | In distribution | |
| SA.005.6530 | In distribution | |
| SA.008.7555 | In distribution | |
| 01.22.936 | In distribution | |
| SA.003.7535 | In distribution | |
| SA.003.6550 | In distribution | |
| SA.R17.0140 | In distribution | |
| SA.005.7545 | In distribution | |
| SA.000.6530 | In distribution | |
| SP.C01.0050 | In distribution | |
| SA.005.5525 | In distribution | |
| SA.003.8545 | In distribution | |
| SA.002.8545 | In distribution | |
| SA.R13.0135 | In distribution | |
| SA.008.6530 | In distribution | |
| SA.000.8545 | In distribution | |
| 01.21.051 | In distribution | |
| SA.003.8055 | In distribution | |
| 01.29.466 | In distribution | |
| SA.005.6540 | In distribution | |
| SA.R16.0105 | In distribution | |
| SA.001.4535 | In distribution | |
| SA.R17.0050 | In distribution | |
| SA.000.8035 | In distribution | |
| SA.000.5545 | In distribution | |
| SA.R17.0060 | In distribution | |
| SA.002.8555 | In distribution | |
| SA.R13.0075 | In distribution | |
| SA.008.4540 | In distribution | |
| SA.006.6530 | In distribution | |
| 01.21.078 | In distribution | |
| SA.R17.0130 | In distribution | |
| SA.000.4555 | In distribution | |
| SA.008.5525 | In distribution | |
| SA.003.8045 | In distribution | |
| SA.R16.0045 | In distribution | |
| SA.002.7525 | In distribution | |
| SA.008.5545 | In distribution | |
| SA.002.4535 | In distribution | |
| SA.005.5535 | In distribution | |
| SA.000.4025 | In distribution | |
| SA.002.5555 | In distribution | |
| SA.008.7545 | In distribution | |
| SA.000.6540 | In distribution | |
| SA.006.5525 | In distribution | |
| 01.22.912 | In distribution | |
| SA.007.6550 | In distribution | |
| SA.006.4540 | In distribution | |
| SA.R55.0070 | In distribution | |
| SA.003.8555 | In distribution | |
| SA.005.5555 | In distribution | |
| SA.R16.0125 | In distribution | |
| SA.R55.0050 | In distribution | |
| SA.R16.0145 | In distribution | |
| 01.21.066 | In distribution | |
| SA.R13.0105 | In distribution | |
| SA.000.6550 | In distribution | |
| 01.28.662 | In distribution | |
| 01.21.039 | In distribution | |
| 01.29.563 | In distribution | |
| SA.000.7545 | In distribution | |
| 01.28.462 | In distribution | |
| SA.000.8535 | In distribution | |
| SA.002.4545 | In distribution | |
| SA.R12.0100 | In distribution | |
| SA.003.4555 | In distribution | |
| SA.R13.0085 | In distribution | |
| SA.001.5525 | In distribution | |
| SA.006.7535 | In distribution | |
| SA.007.7555 | In distribution | |
| SA.003.8535 | In distribution | |
| SA.R16.0085 | In distribution | |
| 01.28.763 | In distribution | |
| SA.008.6540 | In distribution | |
| SA.002.7545 | In distribution | |
| 01.21.072 | In distribution | |
| 01.23.765 | In distribution | |
| SA.R12.0060 | In distribution | |
| SA.007.5555 | In distribution | |
| 01.28.464 | In distribution | |
| SA.000.7555 | In distribution | |
| SA.005.5545 | In distribution | |
| SA.R55.0350 | In distribution | |
| SA.005.4540 | In distribution | |
| SA.001.4035 | In distribution | |
| 01.28.664 | In distribution | |
| 01.22.926 | In distribution | |
| SA.006.4530 | In distribution | |
| SA.000.8055 | In distribution | |
| SP.C01.0035 | In distribution | |
| SA.R16.0095 | In distribution | |
| SA.R12.0050 | In distribution | |
| 01.23.668 | In distribution | |
| SA.003.5525 | In distribution | |
| SA.R13.0145 | In distribution | |
| SA.R55.0110 | In distribution | |
| 01.21.070 | In distribution | |
| SA.R55.0090 | In distribution | |
| SA.R17.0070 | In distribution | |
| SA.006.6550 | In distribution | |
| SA.008.4550 | In distribution | |
| SA.002.7555 | In distribution | |
| SA.R12.0120 | In distribution | |
| SA.R16.0065 | In distribution | |
| 01.21.064 | In distribution | |
| SA.000.4535 | In distribution | |
| SA.000.7535 | In distribution | |
| 01.21.076 | In distribution | |
| 01.21.049 | In distribution | |
| SA.002.6550 | In distribution | |
| SA.007.4530 | In distribution | |
| SA.002.8055 | In distribution | |
| 01.23.767 | In distribution | |
| SA.R17.0150 | In distribution | |
| SA.003.5545 | In distribution | |
| SA.007.6540 | In distribution | |
| SA.R16.0135 | In distribution | |
| SA.002.6540 | In distribution | |
| SA.R55.0190 | In distribution | |
| SA.003.7555 | In distribution | |
| 01.23.763 | In distribution | |
| SA.R12.0090 | In distribution | |
| SA.000.4545 | In distribution | |
| SA.008.5535 | In distribution | |
| 01.21.053 | In distribution | |
| SA.R17.0120 | In distribution | |
| SA.001.4525 | In distribution | |
| SA.005.4530 | In distribution | |
| SA.R12.0070 | In distribution | |
| SA.007.7545 | In distribution | |
| SA.006.5555 | In distribution | |
| 01.21.047 | In distribution | |
| SA.001.7525 | In distribution | |
| SA.000.5525 | In distribution | |
| SA.R13.0115 | In distribution | |
| SA.002.6530 | In distribution | |
| SA.R12.0040 | In distribution | |
| SA.R17.0110 | In distribution | |
| 01.22.934 | In distribution | |
| 01.28.563 | In distribution | |
| SA.001.5555 | In distribution | |
| SA.001.8535 | In distribution | |
| SA.R16.0055 | In distribution | |
| 01.22.932 | In distribution | |
| 01.21.062 | In distribution | |
| SA.005.6550 | In distribution | |
| SA.007.5545 | In distribution | |
| SA.002.8045 | In distribution | |
| SA.006.4550 | In distribution | |
| SA.000.4045 | In distribution | |
| 01.22.916 | In distribution | |
| 01.21.043 | In distribution | |
| SA.R55.0170 | In distribution | |
| SA.R13.0095 | In distribution | |
| 01.29.666 | In distribution | |
| SA.R13.0065 | In distribution | |
| SA.003.5535 | In distribution | |
| SA.R12.0140 | In distribution | |
| SA.001.4045 | In distribution | |
| 01.29.664 | In distribution | |
| SA.R12.0130 | In distribution | |
| SA.007.6530 | In distribution | |
| SA.001.7555 | In distribution | |
| SA.003.5555 | In distribution | |
| SA.R13.0045 | In distribution | |
| 01.28.668 | In distribution | |
| SA.001.4555 | In distribution | |
| SA.R16.0075 | In distribution | |
| SA.006.5545 | In distribution | |
| SA.000.4055 | In distribution | |
| 01.21.074 | In distribution | |
| 01.29.565 | In distribution | |
| SA.R55.0250 | In distribution | |
| 01.29.767 | In distribution | |
| SA.R16.0115 | In distribution | |
| SA.001.8035 | In distribution | |
| SA.001.5545 | In distribution | |
| SA.002.8035 | In distribution | |
| SA.008.7535 | In distribution | |
| SA.008.5555 | In distribution | |
| SA.000.4035 | In distribution | |
| SA.001.8055 | In distribution | |
| SA.007.5525 | In distribution | |
| SA.003.6540 | In distribution | |
| SA.003.7545 | In distribution | |
| SA.006.7555 | In distribution | |
| SA.003.8035 | In distribution |
Showing 250 of 273 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
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.