PreView II™
ACP 4 Level x 101 mm, Swivel Lock
14manufacturers in China registered for this device type
60catalogue 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 | 2026-06-18 (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 |
| Sizes | Length 10 to 109 mm; width 4 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 521170 | Length 60 mm | In distribution |
| 521182 | Length 81 mm | In distribution |
| 521193 | Width 4 mm | In distribution |
| 521160 | Length 45 mm | In distribution |
| 521177 | Length 61 mm | In distribution |
| 521152 | Length 29 mm | In distribution |
| 521191 | Width 4 mm | In distribution |
| 521175 | Length 53 mm | In distribution |
| 521146 | Length 22 mm | In distribution |
| 521140 | Length 12 mm | In distribution |
| 521151 | Length 27 mm | In distribution |
| 521190 | Width 4 mm | In distribution |
| 521197 | Width 4.5 mm | In distribution |
| 521168 | Length 54 mm | In distribution |
| 521185 | Length 93 mm | In distribution |
| 521187 | Length 101 mm | In distribution |
| 521159 | Length 43 mm | In distribution |
| 521165 | Length 45 mm | In distribution |
| 521163 | Length 39 mm | In distribution |
| 521183 | Length 85 mm | In distribution |
| 521173 | Length 69 mm | In distribution |
| 521188 | Length 105 mm | In distribution |
| 521150 | Length 25 mm | In distribution |
| 521178 | Length 65 mm | In distribution |
| 521154 | Length 33 mm | In distribution |
| 521172 | Length 66 mm | In distribution |
| 521162 | Length 36 mm | In distribution |
| 521171 | Length 63 mm | In distribution |
| 521180 | Length 73 mm | In distribution |
| 521147 | Length 24 mm | In distribution |
| 521196 | Width 4.5 mm | In distribution |
| 521153 | Length 31 mm | In distribution |
| 521164 | Length 42 mm | In distribution |
| 521174 | Length 49 mm | In distribution |
| 521141 | Length 13 mm | In distribution |
| 521169 | Length 57 mm | In distribution |
| 521148 | Length 26 mm | In distribution |
| 521138 | Length 10 mm | In distribution |
| 521176 | Length 57 mm | In distribution |
| 521143 | Length 16 mm | In distribution |
| 521184 | Length 89 mm | In distribution |
| 521144 | Length 18 mm | In distribution |
| 521155 | Length 35 mm | In distribution |
| 521181 | Length 77 mm | In distribution |
| 521156 | Length 37 mm | In distribution |
| 521179 | Length 69 mm | In distribution |
| 521142 | Length 14 mm | In distribution |
| 521158 | Length 41 mm | In distribution |
| 521192 | Width 4 mm | In distribution |
| 521149 | Length 23 mm | In distribution |
| 521157 | Length 39 mm | In distribution |
| 521161 | Length 47 mm | In distribution |
| 521195 | Width 4.5 mm | In distribution |
| 521194 | Width 4.5 mm | In distribution |
| 521145 | Length 20 mm | In distribution |
| 521139 | Length 11 mm | In distribution |
| 521166 | Length 48 mm | In distribution |
| 521167 | Length 51 mm | In distribution |
| 521186 | Length 97 mm | In distribution |
| 521189 | Length 109 mm | In distribution |
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.