Medyssey Spinal System – Rod
6.35mm x 450mm CCM Alloy Straight Rod - One Hexa type
13manufacturers in China registered for this device type
665catalogue 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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Medyssey 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 |
| Record published | 2016-08-09 |
| Record revised | 2024-10-08 (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 |
| Distribution end date | 2024-08-19 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RX63105 | In distribution | |
| TR60180 | In distribution | |
| BR63195 | In distribution | |
| CR55035 | In distribution | |
| BR60095 | In distribution | |
| BR55040 | In distribution | |
| CBR55125 | In distribution | |
| RHH55110 | In distribution | |
| CBR55085 | In distribution | |
| RHH60450 | In distribution | |
| CBR63065 | In distribution | |
| RX55075 | In distribution | |
| CRHH55040 | In distribution | |
| RHH63140 | In distribution | |
| TR63160 | In distribution | |
| CBR60125 | In distribution | |
| CRHH60090 | In distribution | |
| RHH55065 | In distribution | |
| RH60180 | In distribution | |
| CRX60045 | In distribution | |
| CR55055 | In distribution | |
| CRX63250 | In distribution | |
| R60150 | In distribution | |
| RXX60110 | In distribution | |
| R63100 | In distribution | |
| CR60150 | In distribution | |
| RXX63050 | In distribution | |
| CRH63045 | In distribution | |
| RHH60065 | In distribution | |
| R55085 | In distribution | |
| RH55100 | In distribution | |
| TR55105 | In distribution | |
| RH55500 | In distribution | |
| CRX63300 | In distribution | |
| CRH60085 | In distribution | |
| CBR63115 | In distribution | |
| CRHH55400 | In distribution | |
| RHH60085 | In distribution | |
| RHH60110 | In distribution | |
| RX63140 | In distribution | |
| CRHH55200 | In distribution | |
| CBR60115 | In distribution | |
| CR63160 | In distribution | |
| RX63040 | In distribution | |
| RH60055 | In distribution | |
| RXX63090 | In distribution | |
| TR60045 | In distribution | |
| CRX55035 | In distribution | |
| BR63055 | In distribution | |
| R55220 | In distribution | |
| CRHH63115 | In distribution | |
| CRX60550 | In distribution | |
| RX55350 | In distribution | |
| CRHH63045 | In distribution | |
| CR63090 | In distribution | |
| RX63200 | In distribution | |
| RXX63200 | In distribution | |
| R60055 | In distribution | |
| RX60055 | In distribution | |
| RH55120 | In distribution | |
| RHH55085 | In distribution | |
| RHH60270 | In distribution | |
| CRH60035 | In distribution | |
| RXX55200 | In distribution | |
| RH55155 | In distribution | |
| CBR60035 | In distribution | |
| BR55105 | In distribution | |
| CRX60035 | In distribution | |
| CRHH60100 | In distribution | |
| BR63135 | In distribution | |
| RH63300 | In distribution | |
| R55035 | In distribution | |
| RHH55160 | In distribution | |
| TR63190 | In distribution | |
| RXX55500 | In distribution | |
| CRHH55250 | In distribution | |
| CRHH60070 | In distribution | |
| CRXX55400 | In distribution | |
| RH63050 | In distribution | |
| CR63500 | In distribution | |
| RH55080 | In distribution | |
| R60180 | In distribution | |
| CRX55110 | In distribution | |
| CR63040 | In distribution | |
| RHH63090 | In distribution | |
| RX63070 | In distribution | |
| RXX63070 | In distribution | |
| RHH55600 | In distribution | |
| CR63060 | In distribution | |
| RX63250 | In distribution | |
| RX60065 | In distribution | |
| CRHH60120 | In distribution | |
| CR55270 | In distribution | |
| CRXX63105 | In distribution | |
| CRHH60160 | In distribution | |
| CRXX55115 | In distribution | |
| CRHH63500 | In distribution | |
| CR60095 | In distribution | |
| TR60035 | In distribution | |
| RHH60550 | In distribution | |
| CRXX60350 | In distribution | |
| R63200 | In distribution | |
| R55095 | In distribution | |
| CR55160 | In distribution | |
| CRXX60075 | In distribution | |
| CR55085 | In distribution | |
| R63800 | In distribution | |
| R55700 | In distribution | |
| RHH55180 | In distribution | |
| CRHH55060 | In distribution | |
| CRHH60600 | In distribution | |
| CBR55055 | In distribution | |
| CRH60220 | In distribution | |
| RH60220 | In distribution | |
| RHH63080 | In distribution | |
| CRXX63140 | In distribution | |
| RXX55070 | In distribution | |
| CRX60150 | In distribution | |
| BR60130 | In distribution | |
| TR60095 | In distribution | |
| BR63155 | In distribution | |
| CBR63105 | In distribution | |
| CRXX63060 | In distribution | |
| RXX55140 | In distribution | |
| TR63090 | In distribution | |
| R60350 | In distribution | |
| CRXX63100 | In distribution | |
| RX63600 | In distribution | |
| CRH60045 | In distribution | |
| RX60045 | In distribution | |
| CRXX63050 | In distribution | |
| CBR63095 | In distribution | |
| RH63100 | In distribution | |
| CRX60075 | In distribution | |
| RXX60085 | In distribution | |
| RXX55120 | In distribution | |
| CRH55055 | In distribution | |
| CRX63060 | In distribution | |
| CBR60155 | In distribution | |
| BR55175 | In distribution | |
| BR55165 | In distribution | |
| CRH60600 | In distribution | |
| CRH60130 | In distribution | |
| R63140 | In distribution | |
| CRX63050 | In distribution | |
| CRHH60500 | In distribution | |
| R60900 | In distribution | |
| BR60165 | In distribution | |
| CBR63195 | In distribution | |
| CRX63035 | In distribution | |
| CRH55115 | In distribution | |
| CRH60500 | In distribution | |
| R60220 | In distribution | |
| CRXX63120 | In distribution | |
| CRXX63080 | In distribution | |
| RXX55400 | In distribution | |
| BR63165 | In distribution | |
| CRH55270 | In distribution | |
| CBR60190 | In distribution | |
| R60110 | In distribution | |
| CRH63055 | In distribution | |
| CR631000 | In distribution | |
| CRXX55155 | In distribution | |
| CR63100 | In distribution | |
| CRH55150 | In distribution | |
| CRH60350 | In distribution | |
| BR60185 | In distribution | |
| RX60220 | In distribution | |
| CR63600 | In distribution | |
| CRH60075 | In distribution | |
| TR60085 | In distribution | |
| CBR60105 | In distribution | |
| TR63100 | In distribution | |
| RX55105 | In distribution | |
| TR55140 | In distribution | |
| RXX55055 | In distribution | |
| CRX55065 | In distribution | |
| CRXX60150 | In distribution | |
| BR60065 | In distribution | |
| CRHH60105 | In distribution | |
| BR60085 | In distribution | |
| CBR55045 | In distribution | |
| R55900 | In distribution | |
| CRHH55155 | In distribution | |
| R63115 | In distribution | |
| R55270 | In distribution | |
| RX55150 | In distribution | |
| BR55195 | In distribution | |
| RH60110 | In distribution | |
| TR63140 | In distribution | |
| RHH60055 | In distribution | |
| CRX63500 | In distribution | |
| CRX55150 | In distribution | |
| R63080 | In distribution | |
| CRXX60045 | In distribution | |
| CBR55200 | In distribution | |
| RX63120 | In distribution | |
| BR63035 | In distribution | |
| R63600 | In distribution | |
| CBR63075 | In distribution | |
| CRXX55250 | In distribution | |
| CR55065 | In distribution | |
| R55350 | In distribution | |
| CRHH60400 | In distribution | |
| RHH63400 | In distribution | |
| CRXX63250 | In distribution | |
| CBR55145 | In distribution | |
| CR63400 | In distribution | |
| RH60450 | In distribution | |
| BR60140 | In distribution | |
| BR55055 | In distribution | |
| RH63060 | In distribution | |
| CRHH55120 | In distribution | |
| CRX63040 | In distribution | |
| RHH63100 | In distribution | |
| RX55130 | In distribution | |
| CRHH63120 | In distribution | |
| CRX60180 | In distribution | |
| TR60150 | In distribution | |
| RHH55500 | In distribution | |
| TR63040 | In distribution | |
| CRHH60050 | In distribution | |
| CR55045 | In distribution | |
| CRH55220 | In distribution | |
| RHH60075 | In distribution | |
| RXX63250 | In distribution | |
| CRH55110 | In distribution | |
| TR55190 | In distribution | |
| CRHH55500 | In distribution | |
| CRXX60095 | In distribution | |
| RXX55080 | In distribution | |
| CBR55190 | In distribution | |
| CRHH63080 | In distribution | |
| CR55130 | In distribution | |
| BR63085 | In distribution | |
| RX60110 | In distribution | |
| CRX63200 | In distribution | |
| TR55100 | In distribution | |
| CR55700 | In distribution | |
| CRHH63065 | In distribution | |
| RX60075 | In distribution | |
| RX63500 | In distribution | |
| TR63105 | In distribution | |
| R60045 | In distribution | |
| CBR63125 | In distribution | |
| TR63060 | In distribution | |
| CRHH55070 | In distribution | |
| RXX55100 | In distribution | |
| BR63105 | In distribution | |
| RX60550 | In distribution |
Showing 250 of 300 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081153 | 2009-01-30 |
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.