M.u.s.t. Pedicle Screw System
MUST LT - Combined setscrew Ti h 3.9mm - (4x) Sterile
14manufacturers in China registered for this device type
162catalogue 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 | Medacta International SA, Switzerland |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K203482 |
| Record published | 2021-02-04 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03.57.041 | In distribution | |
| 03.57.242 | In distribution | |
| 03.59.250 | In distribution | |
| 03.57.903 | In distribution | |
| 03.59.041 | In distribution | |
| 03.57.202 | In distribution | |
| 03.59.015 | In distribution | |
| 03.59.244 | In distribution | |
| 03.59.233 | In distribution | |
| 03.57.238 | In distribution | |
| 03.59.013 | In distribution | |
| 03.59.253 | In distribution | |
| 03.57.251 | In distribution | |
| 03.57.217 | In distribution | |
| 03.57.206 | In distribution | |
| 03.59.007 | In distribution | |
| 03.59.021 | In distribution | |
| 03.59.214 | In distribution | |
| 03.57.246 | In distribution | |
| 03.59.251 | In distribution | |
| 03.57.204 | In distribution | |
| 03.59.039 | In distribution | |
| 03.57.223 | In distribution | |
| 03.57.052 | In distribution | |
| 03.57.221 | In distribution | |
| 03.59.005 | In distribution | |
| 03.57.233 | In distribution | |
| 03.59.248 | In distribution | |
| 03.59.051 | In distribution | |
| 03.59.040 | In distribution | |
| 03.57.256 | In distribution | |
| 03.59.031 | In distribution | |
| 03.59.243 | In distribution | |
| 03.57.054 | In distribution | |
| 03.57.212 | In distribution | |
| 03.57.244 | In distribution | |
| 03.59.049 | In distribution | |
| 03.57.044 | In distribution | |
| 03.59.206 | In distribution | |
| 03.59.037 | In distribution | |
| 03.57.232 | In distribution | |
| 03.59.231 | In distribution | |
| 03.57.211 | In distribution | |
| 03.59.226 | In distribution | |
| 03.57.045 | In distribution | |
| 03.59.026 | In distribution | |
| 03.59.044 | In distribution | |
| 03.59.254 | In distribution | |
| 03.59.215 | In distribution | |
| 03.57.048 | In distribution | |
| 03.57.241 | In distribution | |
| 03.57.240 | In distribution | |
| 03.57.047 | In distribution | |
| 03.57.051 | In distribution | |
| 03.57.236 | In distribution | |
| 03.59.240 | In distribution | |
| 03.59.202 | In distribution | |
| 03.59.033 | In distribution | |
| 03.59.255 | In distribution | |
| 03.59.205 | In distribution | |
| 03.59.247 | In distribution | |
| 03.59.034 | In distribution | |
| 03.57.224 | In distribution | |
| 03.59.241 | In distribution | |
| 03.57.905 | In distribution | |
| 03.59.246 | In distribution | |
| 03.57.245 | In distribution | |
| 03.59.211 | In distribution | |
| 03.59.217 | In distribution | |
| 03.57.247 | In distribution | |
| 03.59.047 | In distribution | |
| 03.59.203 | In distribution | |
| 03.57.215 | In distribution | |
| 03.59.245 | In distribution | |
| 03.59.038 | In distribution | |
| 03.57.053 | In distribution | |
| 03.59.056 | In distribution | |
| 03.57.040 | In distribution | |
| 03.57.255 | In distribution | |
| 03.57.055 | In distribution | |
| 03.57.235 | In distribution | |
| 03.59.222 | In distribution | |
| 03.59.237 | In distribution | |
| 03.59.016 | In distribution | |
| 03.59.036 | In distribution | |
| 03.59.236 | In distribution | |
| 03.57.248 | In distribution | |
| 03.59.053 | In distribution | |
| 03.57.254 | In distribution | |
| 03.59.045 | In distribution | |
| 03.59.232 | In distribution | |
| 03.59.046 | In distribution | |
| 03.57.043 | In distribution | |
| 03.57.237 | In distribution | |
| 03.59.256 | In distribution | |
| 03.57.252 | In distribution | |
| 03.57.213 | In distribution | |
| 03.57.042 | In distribution | |
| 03.59.054 | In distribution | |
| 03.57.203 | In distribution | |
| 03.57.050 | In distribution | |
| 03.59.017 | In distribution | |
| 03.57.239 | In distribution | |
| 03.57.049 | In distribution | |
| 03.57.904 | In distribution | |
| 03.59.012 | In distribution | |
| 03.59.048 | In distribution | |
| 03.59.216 | In distribution | |
| 03.57.216 | In distribution | |
| 03.57.253 | In distribution | |
| 03.59.035 | In distribution | |
| 03.59.042 | In distribution | |
| 03.57.225 | In distribution | |
| 03.59.027 | In distribution | |
| 03.59.225 | In distribution | |
| 03.57.205 | In distribution | |
| 03.57.056 | In distribution | |
| 03.59.238 | In distribution | |
| 03.59.213 | In distribution | |
| 03.57.234 | In distribution | |
| 03.59.022 | In distribution | |
| 03.59.227 | In distribution | |
| 03.59.006 | In distribution | |
| 03.59.223 | In distribution | |
| 03.57.201 | In distribution | |
| 03.59.242 | In distribution | |
| 03.57.243 | In distribution | |
| 03.59.221 | In distribution | |
| 03.59.207 | In distribution | |
| 03.59.055 | In distribution | |
| 03.57.231 | In distribution | |
| 03.59.224 | In distribution | |
| 03.59.212 | In distribution | |
| 03.59.249 | In distribution | |
| 03.59.052 | In distribution | |
| 03.59.235 | In distribution | |
| 03.59.025 | In distribution | |
| 03.57.906 | In distribution | |
| 03.59.032 | In distribution | |
| 03.59.043 | In distribution | |
| 03.59.004 | In distribution | |
| 03.57.249 | In distribution | |
| 03.59.204 | In distribution | |
| 03.57.226 | In distribution | |
| 03.57.227 | In distribution | |
| 03.59.023 | In distribution | |
| 03.59.201 | In distribution | |
| 03.59.050 | In distribution | |
| 03.57.214 | In distribution | |
| 03.59.252 | In distribution | |
| 03.59.234 | In distribution | |
| 03.57.046 | In distribution | |
| 03.59.011 | In distribution | |
| 03.59.024 | In distribution | |
| 03.59.014 | In distribution | |
| 03.59.002 | In distribution | |
| 03.59.239 | In distribution | |
| 03.57.207 | In distribution | |
| 03.57.250 | In distribution | |
| 03.57.222 | In distribution | |
| 03.59.001 | In distribution | |
| 03.59.003 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140361 | 2014-06-12 |
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.