Cassiopeia Cervical Plate System
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical…
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The CASSIOPEIA Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
14manufacturers in China registered for this device type
322catalogue 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 | GS Medical 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 |
| 510(k) | K190170 |
| Record published | 2019-06-18 |
| Record revised | 2025-11-20 (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 |
| Distribution end date | 2019-07-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3320-0012 | In distribution | |
| 3323-0020 | In distribution | |
| 3300-5121 | In distribution | |
| 3300-2046 | In distribution | |
| 3300-1033 | In distribution | |
| 3300-4087 | In distribution | |
| 3300-4099 | In distribution | |
| 3300-3060 | In distribution | |
| 3320-0016 | In distribution | |
| 3300-3074 | In distribution | |
| 3314-0026 | In distribution | |
| 3300-1037 | In distribution | |
| 3326-0014 | In distribution | |
| 3310-0013 | In distribution | |
| 3323-0024 | In distribution | |
| 3322-0020 | In distribution | |
| 3322-0018 | In distribution | |
| 3324-0014 | In distribution | |
| 3322-0024 | In distribution | |
| 3313-0012 | In distribution | |
| 3323-0013 | In distribution | |
| 3316-0014 | In distribution | |
| 3320-0026 | In distribution | |
| 3300-3054 | In distribution | |
| 3322-0012 | In distribution | |
| 3300-4078 | In distribution | |
| 3326-0012 | In distribution | |
| 3300-4097 | In distribution | |
| 3300-4096 | In distribution | |
| 3300-4071 | In distribution | |
| 3300-5092 | In distribution | |
| 3312-0018 | In distribution | |
| 3300-1028 | In distribution | |
| 3300-5088 | In distribution | |
| 3300-5125 | In distribution | |
| 3313-0013 | In distribution | |
| 3300-5097 | In distribution | |
| 3300-5111 | In distribution | |
| 3300-1030 | In distribution | |
| 3300-4072 | In distribution | |
| 3311-0020 | In distribution | |
| 3300-1039 | In distribution | |
| 3311-0015 | In distribution | |
| 3314-0015 | In distribution | |
| 3300-1029 | In distribution | |
| 3300-5112 | In distribution | |
| 3300-1024 | In distribution | |
| 3311-0024 | In distribution | |
| 3300-4091 | In distribution | |
| 3300-1025 | In distribution | |
| 3311-0013 | In distribution | |
| 3300-3064 | In distribution | |
| 3300-4090 | In distribution | |
| 3300-2045 | In distribution | |
| 3300-5119 | In distribution | |
| 3314-0020 | In distribution | |
| 3300-5108 | In distribution | |
| 3300-3070 | In distribution | |
| 3316-0026 | In distribution | |
| 3323-0018 | In distribution | |
| 3300-1021 | In distribution | |
| 3316-0022 | In distribution | |
| 3314-0016 | In distribution | |
| 3310-0016 | In distribution | |
| 3314-0024 | In distribution | |
| 3300-5098 | In distribution | |
| 3321-0026 | In distribution | |
| 3300-4089 | In distribution | |
| 3310-0021 | In distribution | |
| 3300-4095 | In distribution | |
| 3300-4068 | In distribution | |
| 3300-3063 | In distribution | |
| 3300-1022 | In distribution | |
| 3300-5081 | In distribution | |
| 3300-2051 | In distribution | |
| 3314-0018 | In distribution | |
| 3300-3075 | In distribution | |
| 3300-1038 | In distribution | |
| 3324-0012 | In distribution | |
| 3300-5099 | In distribution | |
| 3314-0022 | In distribution | |
| 3300-2040 | In distribution | |
| 3311-0022 | In distribution | |
| 3300-2042 | In distribution | |
| 3323-0026 | In distribution | |
| 3300-5084 | In distribution | |
| 3313-0026 | In distribution | |
| 3310-0026 | In distribution | |
| 3321-0013 | In distribution | |
| 3311-0016 | In distribution | |
| 3321-0024 | In distribution | |
| 3300-5116 | In distribution | |
| 3300-4069 | In distribution | |
| 3310-0020 | In distribution | |
| 3300-5094 | In distribution | |
| 3313-0018 | In distribution | |
| 3300-2050 | In distribution | |
| 3324-0018 | In distribution | |
| 3323-0016 | In distribution | |
| 3300-4101 | In distribution | |
| 3300-2034 | In distribution | |
| 3300-4079 | In distribution | |
| 3310-0014 | In distribution | |
| 3322-0022 | In distribution | |
| 3326-0018 | In distribution | |
| 3312-0013 | In distribution | |
| 3300-4092 | In distribution | |
| 3300-2032 | In distribution | |
| 3311-0014 | In distribution | |
| 3312-0022 | In distribution | |
| 3312-0016 | In distribution | |
| 3320-0022 | In distribution | |
| 3316-0020 | In distribution | |
| 3321-0018 | In distribution | |
| 3300-4088 | In distribution | |
| 3316-0018 | In distribution | |
| 3300-1042 | In distribution | |
| 3300-2035 | In distribution | |
| 3310-0022 | In distribution | |
| 3312-0026 | In distribution | |
| 3300-3072 | In distribution | |
| 3311-0026 | In distribution | |
| 3300-4080 | In distribution | |
| 3300-4067 | In distribution | |
| 3320-0024 | In distribution | |
| 3300-3053 | In distribution | |
| 3326-0026 | In distribution | |
| 3323-0022 | In distribution | |
| 3321-0014 | In distribution | |
| 3300-3076 | In distribution | |
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| 3312-0020 | In distribution | |
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| 3300-3047 | In distribution | |
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| 3300-4065 | In distribution | |
| 3300-5085 | In distribution | |
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| 3300-4073 | In distribution | |
| 3300-4075 | In distribution | |
| 3300-3061 | In distribution | |
| 3316-0013 | In distribution | |
| 3300-5096 | In distribution | |
| 3321-0020 | In distribution | |
| 3300-3059 | In distribution | |
| 3300-5113 | In distribution | |
| 3310-0025 | In distribution | |
| 3300-1035 | In distribution | |
| 3321-0022 | In distribution | |
| 3313-0016 | In distribution | |
| 3300-2054 | In distribution | |
| 3300-4094 | In distribution | |
| 3313-0020 | In distribution | |
| 3300-2049 | In distribution | |
| 3322-0014 | In distribution | |
| 3312-0015 | In distribution | |
| 3300-1040 | In distribution | |
| 3300-5110 | In distribution | |
| 3300-5090 | In distribution | |
| 3300-3077 | In distribution | |
| 3320-0014 | In distribution | |
| 3300-2036 | In distribution | |
| 3300-5122 | In distribution | |
| 3300-1032 | In distribution | |
| 3310-0024 | In distribution | |
| 3324-0015 | In distribution | |
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| 3316-0024 | In distribution | |
| 3300-5114 | In distribution | |
| 3313-0022 | In distribution | |
| 3300-3058 | In distribution | |
| 3300-4070 | In distribution | |
| 3312-0012 | In distribution | |
| 3300-5118 | In distribution | |
| 3310-0012 | In distribution | |
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| 3300-3050 | In distribution | |
| 3314-0012 | In distribution | |
| 3300-1023 | In distribution | |
| 3300-4085 | In distribution | |
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| 3300-1020 | In distribution | |
| 3300-4081 | In distribution | |
| 3300-2038 | In distribution | |
| 3300-4100 | In distribution | |
| 3321-0012 | In distribution | |
| 3300-2039 | In distribution | |
| 3300-2048 | In distribution | |
| 3300-1043 | In distribution | |
| 3300-5115 | In distribution | |
| 3300-3068 | In distribution | |
| 3326-0024 | In distribution | |
| 3300-3057 | In distribution | |
| 3300-3062 | In distribution | |
| 3300-3066 | In distribution | |
| 3314-0013 | In distribution | |
| 3300-2053 | In distribution | |
| 3321-0016 | In distribution | |
| 3300-2047 | In distribution | |
| 3326-0016 | In distribution | |
| 3320-0020 | In distribution | |
| 3310-0015 | In distribution | |
| 3300-4084 | In distribution | |
| 3324-0022 | In distribution | |
| 3300-4082 | In distribution | |
| 3326-0015 | In distribution | |
| 3320-0018 | In distribution | |
| 3300-3049 | In distribution | |
| 3300-5080 | In distribution | |
| 3300-5104 | In distribution | |
| 3300-3065 | In distribution | |
| 3323-0015 | In distribution | |
| 3300-5082 | In distribution | |
| 3326-0020 | In distribution | |
| 3300-4074 | In distribution | |
| 3324-0020 | In distribution | |
| 3300-3073 | In distribution | |
| 3300-4098 | In distribution | |
| 3300-4066 | In distribution | |
| 3300-1019 | In distribution | |
| 3326-0022 | In distribution | |
| 3300-5095 | In distribution | |
| 3300-3071 | In distribution | |
| 3316-0012 | In distribution | |
| 3311-0018 | In distribution | |
| 3310-0018 | In distribution | |
| 3313-0014 | In distribution | |
| 3324-0013 | In distribution | |
| 3312-0014 | In distribution | |
| 3322-0016 | In distribution | |
| 3300-5117 | In distribution | |
| 3300-3052 | In distribution | |
| 3300-3051 | In distribution | |
| 3300-5100 | In distribution | |
| 3300-1026 | In distribution | |
| 3310-0023 | In distribution | |
| 3324-0026 | In distribution | |
| 3316-0016 | In distribution | |
| 3300-1041 | In distribution | |
| 3300-3056 | In distribution | |
| 3316-0015 | In distribution | |
| 3313-0024 | 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 |
|---|---|
| K190170 | 2019-05-13 |
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.