Viper
VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 25mm 5.5 x 6 x 35mm
11manufacturers in China registered for this device type
67catalogue numbers in this listing
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K111571 |
| Record published | 2015-09-24 |
| Record revised | 2025-07-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-12-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 179706280 | In distribution | |
| 186715780 | In distribution | |
| 186720755 | In distribution | |
| 179706260 | In distribution | |
| 179706980 | In distribution | |
| 186717755 | In distribution | |
| 186762655 | In distribution | |
| 186731845 | In distribution | |
| 186715665 | In distribution | |
| 186715440 | In distribution | |
| 179706865 | In distribution | |
| 179704870 | In distribution | |
| 186715835 | In distribution | |
| 186731630 | In distribution | |
| 186715525 | In distribution | |
| 186788070S | In distribution | |
| 186717740 | In distribution | |
| 179706890 | In distribution | |
| 186719770 | In distribution | |
| 186715940 | In distribution | |
| 186715760 | In distribution | |
| 186720655 | In distribution | |
| 186719865 | In distribution | |
| 186731535 | In distribution | |
| 179706275 | In distribution | |
| 186715650 | In distribution | |
| 179706250 | In distribution | |
| 179706940 | In distribution | |
| 179706295 | In distribution | |
| 179706750 | In distribution | |
| 179706165 | In distribution | |
| 179704965 | In distribution | |
| 179706180 | In distribution | |
| 179706270 | In distribution | |
| 186717040 | In distribution | |
| 179706955 | In distribution | |
| 186715655 | In distribution | |
| 186715000 | In distribution | |
| 186762645 | In distribution | |
| 186721735 | In distribution | |
| 179704911 | In distribution | |
| 186717735 | In distribution | |
| 186719065 | In distribution | |
| 186715050 | In distribution | |
| 186715065 | In distribution | |
| 186721545 | In distribution | |
| 186762690 | In distribution | |
| 186720735 | In distribution | |
| 179704899 | In distribution | |
| 179704970 | In distribution | |
| 186762650 | In distribution | |
| 186720535 | In distribution | |
| 186715435 | In distribution | |
| 186788110S | In distribution | |
| 186721555 | In distribution | |
| 179706945 | In distribution | |
| 188104099 | Withdrawn | |
| 188104860 | Withdrawn | |
| 188104770 | Withdrawn | |
| 186742635 | Withdrawn | |
| 188104080 | Withdrawn | |
| 188104090 | Withdrawn | |
| 186770145 | Withdrawn | |
| 188104780 | Withdrawn | |
| 186742530 | Withdrawn | |
| 186770160 | Withdrawn | |
| 186770060 | Withdrawn |
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
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 34 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 36 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 2013-12-24 | |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 24 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 34 uits | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 23 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head | 6 units | 2013-12-24 |
| Depuy Spine, Inc. | 510(k) number | 2012-11-07 | Class II | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head. | 10 units | 2013-12-24 |
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.