Viper
VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 25mm 5.5 x 6 x 30mm
13manufacturers in China registered for this device type
84catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K121020 |
| Record published | 2020-10-06 |
| 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 |
|---|---|---|
| 179706175 | In distribution | |
| 186715040 | In distribution | |
| 186715785 | In distribution | |
| 179706160 | In distribution | |
| 179754770 | In distribution | |
| 186762630 | In distribution | |
| 186719995 | In distribution | |
| 179706265 | In distribution | |
| 186731735 | In distribution | |
| 186717750 | In distribution | |
| 186717640 | In distribution | |
| 179704099 | In distribution | |
| 179706740 | In distribution | |
| 186717530 | In distribution | |
| 186715930 | In distribution | |
| 186715450 | In distribution | |
| 186715840 | In distribution | |
| 186731645 | In distribution | |
| 179706999 | In distribution | |
| 186715055 | In distribution | |
| 186719080 | In distribution | |
| 186731840 | In distribution | |
| 179706755 | In distribution | |
| 179704880 | In distribution | |
| 179706285 | In distribution | |
| 186715625 | In distribution | |
| 186760130 | In distribution | |
| 179706145 | In distribution | |
| 186719785 | In distribution | |
| 186731945 | In distribution | |
| 179704770 | In distribution | |
| 179706745 | In distribution | |
| 186719870 | In distribution | |
| 186760145 | In distribution | |
| 186762675 | In distribution | |
| 186720730 | In distribution | |
| 186731530 | In distribution | |
| 186715670 | In distribution | |
| 179706911 | In distribution | |
| 179706899 | In distribution | |
| 186731740 | In distribution | |
| 186719090 | In distribution | |
| 186715745 | In distribution | |
| 186731430 | In distribution | |
| 186721650 | In distribution | |
| 186762670 | In distribution | |
| 186717650 | In distribution | |
| 179706299 | In distribution | |
| 179704980 | In distribution | |
| 186715635 | In distribution | |
| 186721630 | In distribution | |
| 179706170 | In distribution | |
| 186731950 | In distribution | |
| 186721835 | In distribution | |
| 186788045S | In distribution | |
| 179706990 | In distribution | |
| 186720745 | In distribution | |
| 186720635 | In distribution | |
| 186731545 | In distribution | |
| 186731955 | In distribution | |
| 179706290 | In distribution | |
| 186717055 | In distribution | |
| 186788050S | In distribution | |
| 179704011 | In distribution | |
| 186721655 | In distribution | |
| 186788040S | In distribution | |
| 188104070 | Withdrawn | |
| 188104899 | Withdrawn | |
| 188154765 | Withdrawn | |
| 186775035 | Withdrawn | |
| 188104970 | Withdrawn | |
| 186770035 | Withdrawn | |
| 186742630 | Withdrawn | |
| 188154780 | Withdrawn | |
| 186760050 | Withdrawn | |
| 186742540 | Withdrawn | |
| 186715075 | Withdrawn | |
| 186770065 | Withdrawn | |
| 186750145 | Withdrawn | |
| 186750040 | Withdrawn | |
| 186770040 | Withdrawn | |
| 188154770 | Withdrawn | |
| 186742555 | Withdrawn | |
| 186715085 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
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.