Expedium Verse
EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 x 40mm
2manufacturers in China registered for this device type
26catalogue numbers in this listing
1510(k) clearance
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | PML |
| Device type | Bone Cement, Posterior Screw Augmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| 510(k) | K160879 |
| Record published | 2017-07-25 |
| Record revised | 2024-09-11 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 199723775 | In distribution | |
| 199723565 | In distribution | |
| 199723440 | In distribution | |
| 199723645 | In distribution | |
| 199723555 | In distribution | |
| 199723745 | In distribution | |
| 199723630 | In distribution | |
| 199723535 | In distribution | |
| 199723475 | In distribution | |
| 199723755 | In distribution | |
| 199723570 | In distribution | |
| 199723865 | In distribution | |
| 199723540 | In distribution | |
| 199723455 | In distribution | |
| 199723770 | In distribution | |
| 199723435 | In distribution | |
| 199723740 | In distribution | |
| 199723575 | In distribution | |
| 199723840 | In distribution | |
| 199723875 | In distribution | |
| 199723860 | In distribution | |
| 199723550 | In distribution | |
| 199723655 | In distribution | |
| 199723670 | In distribution | |
| 199723870 | In distribution | |
| 199723730 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 321 |
| M.u.s.t. Pedicle Screw System | Medacta International SA | 248 |
| CarboClear Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 153 |
| Viper | Medos International Sàrl | 32 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160879 | 2016-12-20 |
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.