PreView™
Medfix Rigid Arm, Single Medium 400mm Length Arm, L-Column w/Square QC
14manufacturers in China registered for this device type
137catalogue numbers in this listing
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 | Nexus Spine, L.L.C., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K062371 |
| Record published | 2021-12-17 |
| Record revised | 2025-11-20 (version 6) |
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 |
| Sizes | Length 11 to 109 mm; width 14 to 23 mm |
| Distribution end date | 2023-06-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 521070 | Length 35 mm | In distribution |
| 521063 | Length 26 mm | In distribution |
| 521074 | Length 43 mm | In distribution |
| 521088 | Length 69 mm | In distribution |
| 521085 | Length 60 mm | In distribution |
| 521067 | Length 29 mm | In distribution |
| 521102 | Length 101 mm | In distribution |
| 521084 | Length 57 mm | In distribution |
| 521061 | Length 22 mm | In distribution |
| 521054 | Length 11 mm | In distribution |
| 521104 | Length 109 mm | In distribution |
| 521093 | Length 65 mm | In distribution |
| 521064 | Length 23 mm | In distribution |
| 521075 | Length 45 mm | In distribution |
| 521055 | Length 12 mm | In distribution |
| 521137 | Length 61 mm | In distribution |
| 521065 | Length 25 mm | In distribution |
| 521060 | Length 20 mm | In distribution |
| 521057 | Length 14 mm | In distribution |
| 521095 | Length 73 mm | In distribution |
| 521087 | Length 66 mm | In distribution |
| 521081 | Length 48 mm | In distribution |
| 521083 | Length 54 mm | In distribution |
| 521066 | Length 27 mm | In distribution |
| 521091 | Length 57 mm | In distribution |
| 521077 | Length 36 mm | In distribution |
| 521062 | Length 24 mm | In distribution |
| 521059 | Length 18 mm | In distribution |
| 521056 | Length 13 mm | In distribution |
| 521069 | Length 33 mm | In distribution |
| 521068 | Length 31 mm | In distribution |
| 521099 | Length 89 mm | In distribution |
| 521080 | Length 45 mm | In distribution |
| 521103 | Length 105 mm | In distribution |
| 521071 | Length 37 mm | In distribution |
| 521072 | Length 39 mm | In distribution |
| 521082 | Length 51 mm | In distribution |
| 521096 | Length 77 mm | In distribution |
| 521097 | Length 81 mm | In distribution |
| 521073 | Length 41 mm | In distribution |
| 521101 | Length 97 mm | In distribution |
| 521086 | Length 63 mm | In distribution |
| 521090 | Length 53 mm | In distribution |
| 521076 | Length 47 mm | In distribution |
| 521089 | Length 49 mm | In distribution |
| 521079 | Length 42 mm | In distribution |
| 521100 | Length 93 mm | In distribution |
| 521058 | Length 16 mm | In distribution |
| 521098 | Length 85 mm | In distribution |
| 521092 | Length 61 mm | In distribution |
| 521078 | Length 39 mm | In distribution |
| 521094 | Length 69 mm | In distribution |
| 821055 | In distribution | |
| 821083.17 | Width 23 mm | Withdrawn |
| 821081.12 | Withdrawn | |
| 821081.15 | Width 23 mm | Withdrawn |
| 821083.06 | Width 23 mm | Withdrawn |
| 821081.1 | Withdrawn | |
| 821083.24 | Width 23 mm | Withdrawn |
| 821083.22 | Width 23 mm | Withdrawn |
| 821081.11 | Withdrawn | |
| 821081.13 | Width 23 mm | Withdrawn |
| 821087 | Width 14 mm | Withdrawn |
| 821083 | Withdrawn | |
| 821082.06 | Withdrawn | |
| 821081.14 | Width 23 mm | Withdrawn |
| 821083.41 | Withdrawn | |
| 821080 | Withdrawn | |
| 821081.06 | Width 23 mm | Withdrawn |
| 821083.26 | Width 23 mm | Withdrawn |
| 821083.35 | Withdrawn | |
| 821083.18 | Width 23 mm | Withdrawn |
| 821081.21 | Withdrawn | |
| 821091 | Width 14 mm | Withdrawn |
| 821083.15 | Withdrawn | |
| 821083.32 | Width 14 mm | Withdrawn |
| 821081.19 | Withdrawn | |
| 821083.13 | Width 23 mm | Withdrawn |
| 821023 | Withdrawn | |
| 821081.01 | Withdrawn | |
| 821083.14 | Width 23 mm | Withdrawn |
| 821083.08 | Width 23 mm | Withdrawn |
| 821083.11 | Width 23 mm | Withdrawn |
| 821082.03 | Withdrawn | |
| 821083.03 | Withdrawn | |
| 821083.12 | Width 23 mm | Withdrawn |
| 821083.01 | Withdrawn | |
| 821081.2 | Withdrawn | |
| 821083.39 | Width 14 mm | Withdrawn |
| 821081.23 | Withdrawn | |
| 821083.34 | Withdrawn | |
| 821081.07 | Width 23 mm | Withdrawn |
| 821081.05 | Width 23 mm | Withdrawn |
| 821081 | Withdrawn | |
| 821083.25 | Width 23 mm | Withdrawn |
| 821083.02 | Withdrawn | |
| 821082.04 | Withdrawn | |
| 821083.2 | Withdrawn | |
| 821082.01 | Withdrawn | |
| 821088 | Width 14 mm | Withdrawn |
| 821086 | Width 14 mm | Withdrawn |
| 821083.21 | Width 23 mm | Withdrawn |
| 821083.04 | Width 23 mm | Withdrawn |
| 821083.28 | Width 23 mm | Withdrawn |
| 821068 | Withdrawn | |
| 821081.09 | Withdrawn | |
| 821083.1 | Width 23 mm | Withdrawn |
| 821081.04 | Width 23 mm | Withdrawn |
| 821081.22 | Withdrawn | |
| 821089 | Width 14 mm | Withdrawn |
| 821082.02 | Withdrawn | |
| 821083.19 | Width 23 mm | Withdrawn |
| 821083.23 | Width 23 mm | Withdrawn |
| 821082.05 | Withdrawn | |
| 821083.33 | Withdrawn | |
| 821081.08 | Width 23 mm | Withdrawn |
| 821083.38 | Width 14 mm | Withdrawn |
| 821085 | Withdrawn | |
| 821083.29 | Width 23 mm | Withdrawn |
| 821083.27 | Width 23 mm | Withdrawn |
| 821083.36 | Width 23 mm | Withdrawn |
| 821081.02 | Withdrawn | |
| 821081.03 | Withdrawn | |
| 821083.31 | Width 14 mm | Withdrawn |
| 821083.07 | Width 23 mm | Withdrawn |
| 821083.42 | Withdrawn | |
| 821083.05 | Width 23 mm | Withdrawn |
| 821083.09 | Withdrawn | |
| 821081.18 | Withdrawn | |
| 821081.17 | Width 23 mm | Withdrawn |
| 821083.37 | Width 23 mm | Withdrawn |
| 821083.3 | Width 14 mm | Withdrawn |
| 821083.4 | Width 14 mm | Withdrawn |
| 821083.16 | Width 23 mm | Withdrawn |
| 821082 | Withdrawn | |
| 821090 | Width 14 mm | Withdrawn |
| 821081.16 | Width 23 mm | Withdrawn |
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
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.