Z-Pedicle Screw
42 catalogue numbers from A06 464, listed by Z-Medical Gmbh & Co. KG, Germany, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
42catalogue 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, Spinal Pedicle Fixation
Record
| Listed by | Z-Medical Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2024-07-05 |
| Record revised | 2024-09-11 (version 3) |
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 |
|---|---|---|
| A06 464 | In distribution | |
| A06 272 | In distribution | |
| A06 462 | In distribution | |
| A06 495 | In distribution | |
| A06 273 | In distribution | |
| A06 465 | In distribution | |
| A06 262 | In distribution | |
| A06 051 | In distribution | |
| A06 473 | In distribution | |
| A06 265 | In distribution | |
| A06 451 | In distribution | |
| A06 454 | In distribution | |
| A06 061 | In distribution | |
| A06 065 | In distribution | |
| A06 474 | In distribution | |
| A06 271 | In distribution | |
| A06 492 | In distribution | |
| A06 463 | In distribution | |
| A06 472 | In distribution | |
| A06 491 | In distribution | |
| A06 295 | In distribution | |
| A06 274 | In distribution | |
| A06 251 | In distribution | |
| A06 064 | In distribution | |
| A06 261 | In distribution | |
| A06 292 | In distribution | |
| A06 493 | In distribution | |
| A06 263 | In distribution | |
| A06 461 | In distribution | |
| A06 453 | In distribution | |
| A06 275 | In distribution | |
| A06 293 | In distribution | |
| A06 291 | In distribution | |
| A06 471 | In distribution | |
| A06 264 | In distribution | |
| A06 252 | In distribution | |
| A06 475 | In distribution | |
| A06 294 | In distribution | |
| A06 452 | In distribution | |
| A06 494 | In distribution | |
| A06 254 | In distribution | |
| A06 171 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.