Auxein Brand Vertaux 5.5 Mm Pedicle Screw System
VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 30mm, Titanium
15manufacturers in China registered for this device type
127catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Auxein medical Private limited, India |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K201457 |
| Record published | 2021-07-09 |
| Record revised | 2025-07-02 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP-335 | In distribution | |
| SP-314 | In distribution | |
| SP-344 | In distribution | |
| SP-932 | In distribution | |
| SP-313 | In distribution | |
| SP-212 | In distribution | |
| SP-244 | In distribution | |
| SP-239 | In distribution | |
| SP-945 | In distribution | |
| SP-1634 | In distribution | |
| SP-223 | In distribution | |
| SP-222 | In distribution | |
| SP-938 | In distribution | |
| SP-316 | In distribution | |
| SP-1642 | In distribution | |
| SP-229 | In distribution | |
| SP-319 | In distribution | |
| SP-216 | In distribution | |
| SP-242 | In distribution | |
| SP-937 | In distribution | |
| SP-336 | In distribution | |
| SP-243 | In distribution | |
| SP-940 | In distribution | |
| SP-308 | In distribution | |
| SP-254 | In distribution | |
| SP-233 | In distribution | |
| SP-903 | In distribution | |
| SP-931 | In distribution | |
| SP-208 | In distribution | |
| SP-342 | In distribution | |
| SP-346 | In distribution | |
| SP-209 | In distribution | |
| SP-252 | In distribution | |
| SP-929 | In distribution | |
| SP-211 | In distribution | |
| SP-217 | In distribution | |
| SP-215 | In distribution | |
| SP-924 | In distribution | |
| SP-1662 | In distribution | |
| SP-322 | In distribution | |
| SP-904 | In distribution | |
| SP-332 | In distribution | |
| SP-236 | In distribution | |
| SP-925 | In distribution | |
| SP-304 | In distribution | |
| SP-220 | In distribution | |
| SP-303 | In distribution | |
| SP-334 | In distribution | |
| SP-347 | In distribution | |
| SP-305 | In distribution | |
| SP-250 | In distribution | |
| SP-326 | In distribution | |
| SP-1645 | In distribution | |
| SP-333 | In distribution | |
| SP-213 | In distribution | |
| SP-309 | In distribution | |
| SP-247 | In distribution | |
| SP-936 | In distribution | |
| SP-219 | In distribution | |
| SP-221 | In distribution | |
| SP-1637 | In distribution | |
| SP-235 | In distribution | |
| SP-310 | In distribution | |
| SP-928 | In distribution | |
| SP-1661 | In distribution | |
| SP-214 | In distribution | |
| SP-930 | In distribution | |
| SP-321 | In distribution | |
| SP-240 | In distribution | |
| SP-253 | In distribution | |
| SP-330 | In distribution | |
| SP-227 | In distribution | |
| SP-245 | In distribution | |
| SP-1649 | In distribution | |
| SP-241 | In distribution | |
| SP-939 | In distribution | |
| SP-307 | In distribution | |
| SP-327 | In distribution | |
| SP-237 | In distribution | |
| SP-927 | In distribution | |
| SP-338 | In distribution | |
| SP-329 | In distribution | |
| SP-1641 | In distribution | |
| SP-345 | In distribution | |
| SP-228 | In distribution | |
| SP-306 | In distribution | |
| SP-231 | In distribution | |
| SP-251 | In distribution | |
| SP-207 | In distribution | |
| SP-218 | In distribution | |
| SP-325 | In distribution | |
| SP-328 | In distribution | |
| SP-315 | In distribution | |
| SP-331 | In distribution | |
| SP-944 | In distribution | |
| SP-224 | In distribution | |
| SP-317 | In distribution | |
| SP-249 | In distribution | |
| SP-234 | In distribution | |
| SP-225 | In distribution | |
| SP-1650 | In distribution | |
| SP-248 | In distribution | |
| SP-246 | In distribution | |
| SP-340 | In distribution | |
| SP-1638 | In distribution | |
| SP-472 | In distribution | |
| SP-210 | In distribution | |
| SP-339 | In distribution | |
| SP-934 | In distribution | |
| SP-324 | In distribution | |
| SP-311 | In distribution | |
| SP-230 | In distribution | |
| SP-935 | In distribution | |
| SP-941 | In distribution | |
| SP-341 | In distribution | |
| SP-238 | In distribution | |
| SP-232 | In distribution | |
| SP-1646 | In distribution | |
| SP-320 | In distribution | |
| SP-318 | In distribution | |
| SP-343 | In distribution | |
| SP-943 | In distribution | |
| SP-312 | In distribution | |
| SP-337 | In distribution | |
| SP-348 | In distribution | |
| SP-942 | In distribution | |
| SP-323 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
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.