M.u.s.t. Pedicle Screw System
Fenestrated polyax. cann. ped. scr. 9x80,dual-diam
2manufacturers in China registered for this device type
248catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medacta International SA, Switzerland |
|---|---|
| FDA product code | PML |
| Device type | Bone Cement, Posterior Screw Augmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K241034 |
| Record published | 2024-07-08 |
| Record revised | 2024-09-25 (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 |
|---|---|---|
| 03.52.217 | In distribution | |
| 03.77.232 | In distribution | |
| 03.61.379 | In distribution | |
| 03.79.015 | In distribution | |
| 03.61.399 | In distribution | |
| 03.77.040 | In distribution | |
| 03.77.251 | In distribution | |
| 03.79.047 | In distribution | |
| 03.61.371 | In distribution | |
| 03.77.038 | In distribution | |
| 03.77.216 | In distribution | |
| 03.61.312 | In distribution | |
| 03.79.049 | In distribution | |
| 03.79.243 | In distribution | |
| 03.77.240 | In distribution | |
| 03.79.233 | In distribution | |
| 03.77.024 | In distribution | |
| 03.77.227 | In distribution | |
| 03.61.116 | In distribution | |
| 03.61.363 | In distribution | |
| 03.61.119 | In distribution | |
| 03.77.004 | In distribution | |
| 03.77.236 | In distribution | |
| 03.79.215 | In distribution | |
| 03.61.340 | In distribution | |
| 03.79.013 | In distribution | |
| 03.79.052 | In distribution | |
| 03.77.048 | In distribution | |
| 03.77.021 | In distribution | |
| 03.77.031 | In distribution | |
| 03.79.241 | In distribution | |
| 03.61.322 | In distribution | |
| 03.79.253 | In distribution | |
| 03.77.234 | In distribution | |
| 03.79.045 | In distribution | |
| 03.77.003 | In distribution | |
| 03.79.054 | In distribution | |
| 03.77.044 | In distribution | |
| 03.79.004 | In distribution | |
| 03.77.203 | In distribution | |
| 03.79.231 | In distribution | |
| 03.77.245 | In distribution | |
| 03.77.032 | In distribution | |
| 03.79.246 | In distribution | |
| 03.77.049 | In distribution | |
| 03.77.221 | In distribution | |
| 03.79.212 | In distribution | |
| 03.77.217 | In distribution | |
| 03.79.240 | In distribution | |
| 03.77.005 | In distribution | |
| 03.61.354 | In distribution | |
| 03.77.248 | In distribution | |
| 03.79.254 | In distribution | |
| 03.61.316 | In distribution | |
| 03.61.315 | In distribution | |
| 03.79.207 | In distribution | |
| 03.79.223 | In distribution | |
| 03.77.250 | In distribution | |
| 03.79.044 | In distribution | |
| 03.79.038 | In distribution | |
| 03.79.217 | In distribution | |
| 03.77.213 | In distribution | |
| 03.61.381 | In distribution | |
| 03.77.014 | In distribution | |
| 03.61.317 | In distribution | |
| 03.77.242 | In distribution | |
| 03.77.255 | In distribution | |
| 03.77.214 | In distribution | |
| 03.61.336 | In distribution | |
| 03.79.206 | In distribution | |
| 03.79.237 | In distribution | |
| 03.61.389 | In distribution | |
| 03.61.325 | In distribution | |
| 03.77.241 | In distribution | |
| 03.79.248 | In distribution | |
| 03.79.040 | In distribution | |
| 03.61.355 | In distribution | |
| 03.79.242 | In distribution | |
| 03.79.027 | In distribution | |
| 03.79.006 | In distribution | |
| 03.79.046 | In distribution | |
| 03.77.035 | In distribution | |
| 03.79.211 | In distribution | |
| 03.61.339 | In distribution | |
| 03.61.338 | In distribution | |
| 03.77.204 | In distribution | |
| 03.79.051 | In distribution | |
| 03.61.398 | In distribution | |
| 03.52.207 | In distribution | |
| 03.61.337 | In distribution | |
| 03.77.034 | In distribution | |
| 03.77.053 | In distribution | |
| 03.77.015 | In distribution | |
| 03.61.395 | In distribution | |
| 03.61.393 | In distribution | |
| 03.77.025 | In distribution | |
| 03.79.016 | In distribution | |
| 03.79.001 | In distribution | |
| 03.77.238 | In distribution | |
| 03.79.043 | In distribution | |
| 03.77.041 | In distribution | |
| 03.77.037 | In distribution | |
| 03.61.358 | In distribution | |
| 03.61.392 | In distribution | |
| 03.77.001 | In distribution | |
| 03.77.011 | In distribution | |
| 03.79.252 | In distribution | |
| 03.77.006 | In distribution | |
| 03.79.213 | In distribution | |
| 03.79.022 | In distribution | |
| 03.77.023 | In distribution | |
| 03.77.047 | In distribution | |
| 03.77.237 | In distribution | |
| 03.77.249 | In distribution | |
| 03.61.386 | In distribution | |
| 03.79.037 | In distribution | |
| 03.61.118 | In distribution | |
| 03.79.011 | In distribution | |
| 03.77.246 | In distribution | |
| 03.77.026 | In distribution | |
| 03.61.387 | In distribution | |
| 03.77.201 | In distribution | |
| 03.77.244 | In distribution | |
| 03.77.212 | In distribution | |
| 03.79.042 | In distribution | |
| 03.79.041 | In distribution | |
| 03.77.211 | In distribution | |
| 03.79.034 | In distribution | |
| 03.77.205 | In distribution | |
| 03.77.051 | In distribution | |
| 03.79.014 | In distribution | |
| 03.77.202 | In distribution | |
| 03.79.221 | In distribution | |
| 03.61.372 | In distribution | |
| 03.77.022 | In distribution | |
| 03.79.235 | In distribution | |
| 03.61.374 | In distribution | |
| 03.77.039 | In distribution | |
| 03.77.231 | In distribution | |
| 03.77.204 | In distribution | |
| 03.61.353 | In distribution | |
| 03.77.017 | In distribution | |
| 03.79.222 | In distribution | |
| 03.79.017 | In distribution | |
| 03.79.002 | In distribution | |
| 03.61.357 | In distribution | |
| 03.79.025 | In distribution | |
| 03.61.117 | In distribution | |
| 03.79.036 | In distribution | |
| 03.77.016 | In distribution | |
| 03.79.056 | In distribution | |
| 03.77.013 | In distribution | |
| 03.61.323 | In distribution | |
| 03.61.326 | In distribution | |
| 03.77.243 | In distribution | |
| 03.77.036 | In distribution | |
| 03.79.012 | In distribution | |
| 03.77.201 | In distribution | |
| 03.79.255 | In distribution | |
| 03.79.247 | In distribution | |
| 03.77.222 | In distribution | |
| 03.77.247 | In distribution | |
| 03.79.245 | In distribution | |
| 03.77.225 | In distribution | |
| 03.79.021 | In distribution | |
| 03.79.032 | In distribution | |
| 03.77.052 | In distribution | |
| 03.77.206 | In distribution | |
| 03.79.048 | In distribution | |
| 03.79.251 | In distribution | |
| 03.61.314 | In distribution | |
| 03.79.250 | In distribution | |
| 03.77.224 | In distribution | |
| 03.79.238 | In distribution | |
| 03.61.390 | In distribution | |
| 03.77.226 | In distribution | |
| 03.61.120 | In distribution | |
| 03.77.202 | In distribution | |
| 03.77.233 | In distribution | |
| 03.79.003 | In distribution | |
| 03.61.377 | In distribution | |
| 03.79.249 | In distribution | |
| 03.79.256 | In distribution | |
| 03.61.115 | In distribution | |
| 03.79.055 | In distribution | |
| 03.79.053 | In distribution | |
| 03.79.224 | In distribution | |
| 03.77.223 | In distribution | |
| 03.52.216 | In distribution | |
| 03.77.043 | In distribution | |
| 03.79.225 | In distribution | |
| 03.77.235 | In distribution | |
| 03.61.397 | In distribution | |
| 03.79.023 | In distribution | |
| 03.79.024 | In distribution | |
| 03.79.007 | In distribution | |
| 03.77.239 | In distribution | |
| 03.77.254 | In distribution | |
| 03.61.324 | In distribution | |
| 03.61.388 | In distribution | |
| 03.77.050 | In distribution | |
| 03.77.012 | In distribution | |
| 03.79.214 | In distribution | |
| 03.77.033 | In distribution | |
| 03.79.226 | In distribution | |
| 03.61.394 | In distribution | |
| 03.52.206 | In distribution | |
| 03.79.026 | In distribution | |
| 03.61.396 | In distribution | |
| 03.77.056 | In distribution | |
| 03.77.045 | In distribution | |
| 03.79.236 | In distribution | |
| 03.77.054 | In distribution | |
| 03.61.313 | In distribution | |
| 03.61.321 | In distribution | |
| 03.61.391 | In distribution | |
| 03.61.335 | In distribution | |
| 03.61.373 | In distribution | |
| 03.77.205 | In distribution | |
| 03.77.252 | In distribution | |
| 03.77.253 | In distribution | |
| 03.79.239 | In distribution | |
| 03.77.046 | In distribution | |
| 03.77.215 | In distribution | |
| 03.77.203 | In distribution | |
| 03.52.227 | In distribution | |
| 03.77.055 | In distribution | |
| 03.61.361 | In distribution | |
| 03.79.005 | In distribution | |
| 03.77.207 | In distribution | |
| 03.79.035 | In distribution | |
| 03.77.007 | In distribution | |
| 03.77.002 | In distribution | |
| 03.61.365 | In distribution | |
| 03.79.033 | In distribution | |
| 03.79.227 | In distribution | |
| 03.79.216 | In distribution | |
| 03.77.042 | In distribution | |
| 03.79.039 | In distribution | |
| 03.79.234 | In distribution | |
| 03.79.232 | In distribution | |
| 03.61.385 | In distribution | |
| 03.77.256 | In distribution | |
| 03.79.050 | In distribution | |
| 03.61.356 | In distribution | |
| 03.79.244 | In distribution | |
| 03.77.027 | In distribution | |
| 03.79.031 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 321 |
| CarboClear Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 153 |
| Viper | Medos International Sàrl | 32 |
| Expedium Verse | Medos International Sàrl | 26 |
| CarboClear X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 18 |
| Vader Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 55 mm | Icotec AG | 13 |
| CarboClear Modular Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 11 |
| CarboClear Pedicle Screw System | CarboFix Orthopedics, Ltd. | 9 |
| icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 45 mm | Icotec AG | 6 |
| Vader Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 | Icotec AG | 1 |
| Romeo® 2 | Spineart SA | 1 |
| Vader Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm | Icotec AG | 1 |
Showing 12 of 14. All products under Bone Cement, Posterior Screw Augmentation
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.