TranS1
AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 40 mm Length
14manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Quandary Medical LLC |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K102334 |
| Record published | 2016-09-15 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TR1-23100 | In distribution | |
| TR1-23105 | In distribution | |
| TR1-2357 | In distribution | |
| TR1-2384 | In distribution | |
| TR1-2394 | In distribution | |
| TR1-2361 | In distribution | |
| TR1-2364 | In distribution | |
| TR1-2389 | In distribution | |
| TR1-2391 | In distribution | |
| TR1-2382 | In distribution | |
| TR1-2365 | In distribution | |
| TR1-2366 | In distribution | |
| TR1-2395 | In distribution | |
| TR1-2380 | In distribution | |
| TR1-2367 | In distribution | |
| TR1-2385 | In distribution | |
| TR1-2358 | In distribution | |
| TR1-2381 | In distribution | |
| TR1-2372 | In distribution | |
| TR1-2360 | In distribution | |
| TR1-2378 | In distribution | |
| TR1-2390 | In distribution | |
| TR1-2398 | In distribution | |
| TR1-23104 | In distribution | |
| TR1-2388 | In distribution | |
| TR1-2373 | In distribution | |
| TR1-2221 | In distribution | |
| TR1-2375 | In distribution | |
| TR1-2386 | In distribution | |
| TR1-2397 | In distribution | |
| TR1-2393 | In distribution | |
| TR1-2392 | In distribution | |
| TR1-2399 | In distribution | |
| TR1-23103 | In distribution | |
| TR1-23101 | In distribution | |
| TR1-2387 | In distribution | |
| TR1-23102 | In distribution | |
| TR1-2368 | In distribution | |
| TR1-2363 | In distribution | |
| TR1-2396 | In distribution | |
| TR1-2379 | In distribution | |
| TR1-2359 | In distribution | |
| TR1-2374 | In distribution | |
| TR1-2362 | In distribution | |
| TR1-2383 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
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.