Viper
VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 10 x 70mm
2manufacturers in China registered for this device type
32catalogue 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 | 2017-05-02 |
| 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 |
|---|---|---|
| 186727570 | In distribution | |
| 186727950 | In distribution | |
| 186727775 | In distribution | |
| 186727640 | In distribution | |
| 186727530 | In distribution | |
| 186727975 | In distribution | |
| 186727935 | In distribution | |
| 186727930 | In distribution | |
| 186727565 | In distribution | |
| 186727865 | In distribution | |
| 186727070 | In distribution | |
| 186727535 | In distribution | |
| 186727665 | In distribution | |
| 186727035 | In distribution | |
| 186727835 | In distribution | |
| 186727850 | In distribution | |
| 186727635 | In distribution | |
| 186727555 | In distribution | |
| 186727075 | In distribution | |
| 186727765 | In distribution | |
| 186727660 | In distribution | |
| 186727770 | In distribution | |
| 186727965 | In distribution | |
| 186727055 | In distribution | |
| 186727760 | In distribution | |
| 186727745 | In distribution | |
| 186727065 | In distribution | |
| 186727575 | In distribution | |
| 186727630 | In distribution | |
| 186727580 | In distribution | |
| 186727955 | In distribution | |
| 186727645 | 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 |
| 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
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.