Preference Pedicle Screw System
Rod, Curved, CoCr, Ext. Hex, Ø5.5mm, L=120mm, R=288mm
11manufacturers in China registered for this device type
65catalogue 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 | CTL Medical Corporation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K081296 |
| Record published | 2023-09-09 |
| Record revised | 2026-06-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-2000-110 | In distribution | |
| 11-4000-001 | In distribution | |
| 10-2900-045 | In distribution | |
| 25-2200-350 | In distribution | |
| 25-2000-030 | In distribution | |
| 25-2000-085 | In distribution | |
| 25-2002-070 | In distribution | |
| 25-2000-075 | In distribution | |
| 25-2200-040 | In distribution | |
| 10-2961-524 | In distribution | |
| 25-2000-120 | In distribution | |
| 25-2200-050 | In distribution | |
| 25-2002-030 | In distribution | |
| 055.8302 | In distribution | |
| 25-2201-250 | In distribution | |
| 25-2002-120 | In distribution | |
| 25-2000-060 | In distribution | |
| 24-4000-127 | In distribution | |
| 25-2002-045 | In distribution | |
| 25-2002-050 | In distribution | |
| 25-2002-055 | In distribution | |
| 25-2200-250 | In distribution | |
| 25-2002-065 | In distribution | |
| 25-2000-050 | In distribution | |
| 10-2900-055 | In distribution | |
| 25-2000-040 | In distribution | |
| 25-2002-110 | In distribution | |
| 25-2201-450 | In distribution | |
| 055.8108 | In distribution | |
| 25-2202-350 | In distribution | |
| 25-2000-080 | In distribution | |
| 25-2002-090 | In distribution | |
| 25-2002-130 | In distribution | |
| 10-2900-070 | In distribution | |
| 25-2201-150 | In distribution | |
| 25-2202-450 | In distribution | |
| 10-2961-526 | In distribution | |
| 25-2000-250 | In distribution | |
| 25-2002-040 | In distribution | |
| 25-2202-150 | In distribution | |
| 25-2202-600 | In distribution | |
| 25-2000-130 | In distribution | |
| 25-2002-100 | In distribution | |
| 10-2961-532 | In distribution | |
| 25-2000-035 | In distribution | |
| 25-2000-100 | In distribution | |
| 25-2200-030 | In distribution | |
| 10-2961-522 | In distribution | |
| 25-2201-350 | In distribution | |
| 10-2900-090 | In distribution | |
| 25-2000-070 | In distribution | |
| 25-2200-450 | In distribution | |
| 25-2002-060 | In distribution | |
| 25-2000-090 | In distribution | |
| 25-2000-065 | In distribution | |
| 25-2000-055 | In distribution | |
| 25-2000-045 | In distribution | |
| 27-4000-091 | In distribution | |
| 25-2200-150 | In distribution | |
| 25-2002-035 | In distribution | |
| 25-2202-250 | In distribution | |
| 10-2961-520 | In distribution | |
| 25-2201-600 | In distribution | |
| 055.8303 | In distribution | |
| 25-2002-080 | In distribution |
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
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.