M.u.s.t. Mini Posterior Cervical Screws
MUST MINI Cannulated Polyaxial Screw 4.5 x 46 Partial thread + nut
11manufacturers in China registered for this device type
79catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medacta International SA, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K200130 |
| Record published | 2020-06-15 |
| Record revised | 2024-10-01 (version 2) |
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 |
|---|---|---|
| 03.75.304 | In distribution | |
| 03.75.736 | In distribution | |
| 03.75.256 | In distribution | |
| 03.75.474 | In distribution | |
| 03.75.252 | In distribution | |
| 03.75.475 | In distribution | |
| 03.75.273 | In distribution | |
| 03.75.478 | In distribution | |
| 03.75.303 | In distribution | |
| 03.75.582 | In distribution | |
| 03.75.365 | In distribution | |
| 03.75.276 | In distribution | |
| 03.75.402 | In distribution | |
| 03.75.738 | In distribution | |
| 03.75.584 | In distribution | |
| 03.75.253 | In distribution | |
| 03.75.374 | In distribution | |
| 03.75.372 | In distribution | |
| 03.75.263 | In distribution | |
| 03.75.281 | In distribution | |
| 03.75.371 | In distribution | |
| 03.75.509 | In distribution | |
| 03.75.262 | In distribution | |
| 03.75.477 | In distribution | |
| 03.75.282 | In distribution | |
| 03.75.558 | In distribution | |
| 03.75.260 | In distribution | |
| 03.75.270 | In distribution | |
| 03.75.407 | In distribution | |
| 03.75.364 | In distribution | |
| 03.75.583 | In distribution | |
| 03.75.302 | In distribution | |
| 03.75.255 | In distribution | |
| 03.75.274 | In distribution | |
| 03.75.354 | In distribution | |
| 03.75.403 | In distribution | |
| 03.75.285 | In distribution | |
| 03.75.284 | In distribution | |
| 03.75.305 | In distribution | |
| 03.75.366 | In distribution | |
| 03.75.271 | In distribution | |
| 03.75.261 | In distribution | |
| 03.75.557 | In distribution | |
| 03.75.283 | In distribution | |
| 03.75.275 | In distribution | |
| 03.75.265 | In distribution | |
| 03.75.272 | In distribution | |
| 03.75.737 | In distribution | |
| 03.75.250 | In distribution | |
| 03.75.512 | In distribution | |
| 03.75.264 | In distribution | |
| 03.75.355 | In distribution | |
| 03.75.361 | In distribution | |
| 03.75.280 | In distribution | |
| 03.75.581 | In distribution | |
| 03.75.266 | In distribution | |
| 03.75.251 | In distribution | |
| 03.75.352 | In distribution | |
| 03.75.353 | In distribution | |
| 03.75.473 | In distribution | |
| 03.75.406 | In distribution | |
| 03.75.476 | In distribution | |
| 03.75.363 | In distribution | |
| 03.75.254 | In distribution | |
| 03.75.373 | In distribution | |
| 03.75.370 | In distribution | |
| 03.75.404 | In distribution | |
| 03.75.405 | In distribution | |
| 03.75.351 | In distribution | |
| 03.75.362 | In distribution | |
| 03.75.511 | In distribution | |
| 03.75.360 | In distribution | |
| 03.75.510 | In distribution | |
| 03.75.356 | In distribution | |
| 03.75.375 | In distribution | |
| 03.75.735 | In distribution | |
| 03.75.350 | In distribution | |
| 03.75.471 | In distribution | |
| 03.75.472 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121115 | 2012-07-18 |
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.