Fuse ACP
Fuse-ACP Variable Self Drilling Screw ø4.35 X 11mm
14manufacturers in China registered for this device type
145catalogue 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 | Alpha AI Co., Ltd., South Korea |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| 510(k) | K182489 |
| Record published | 2020-10-24 |
| Record revised | 2026-01-19 (version 6) |
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 |
|---|---|---|
| F8014-0120 | In distribution | |
| F8224-4310 | In distribution | |
| F8014-0357 | In distribution | |
| F8227-4310 | In distribution | |
| F8014-0240 | In distribution | |
| F8014-0466 | In distribution | |
| F8014-0116 | In distribution | |
| F8227-4319 | In distribution | |
| F8226-4311 | In distribution | |
| F8014-0224 | In distribution | |
| F8227-4011 | In distribution | |
| F8227-4314 | In distribution | |
| F8014-0246 | In distribution | |
| F8014-0571 | In distribution | |
| F8224-4318 | In distribution | |
| F8224-4013 | In distribution | |
| F8225-4017 | In distribution | |
| F8014-0222 | In distribution | |
| F8226-4322 | In distribution | |
| F8225-4011 | In distribution | |
| F8225-4320 | In distribution | |
| F8225-4019 | In distribution | |
| F8226-4018 | In distribution | |
| F8227-4016 | In distribution | |
| F8226-4019 | In distribution | |
| F8227-4017 | In distribution | |
| F8227-4020 | In distribution | |
| F8225-4313 | In distribution | |
| F8014-0354 | In distribution | |
| F8014-0474 | In distribution | |
| F8224-4015 | In distribution | |
| F8226-4017 | In distribution | |
| F8227-4312 | In distribution | |
| F8226-4014 | In distribution | |
| F8014-0242 | In distribution | |
| F8014-0226 | In distribution | |
| F8014-0234 | In distribution | |
| F8014-0236 | In distribution | |
| F8224-4022 | In distribution | |
| F8225-4012 | In distribution | |
| F8014-0348 | In distribution | |
| F8014-0366 | In distribution | |
| F8227-4317 | In distribution | |
| F8226-4022 | In distribution | |
| F8225-4318 | In distribution | |
| F8224-4016 | In distribution | |
| F8224-4319 | In distribution | |
| F8226-4314 | In distribution | |
| F8225-4022 | In distribution | |
| F8014-0454 | In distribution | |
| F8227-4022 | In distribution | |
| F8226-4313 | In distribution | |
| F8227-4012 | In distribution | |
| F8225-4018 | In distribution | |
| F8224-4312 | In distribution | |
| F8227-4010 | In distribution | |
| F8224-4313 | In distribution | |
| F8014-0478 | In distribution | |
| F8227-4315 | In distribution | |
| F8014-0581 | In distribution | |
| F8014-0110 | In distribution | |
| F8226-4010 | In distribution | |
| F8227-4015 | In distribution | |
| F8014-0114 | In distribution | |
| F8225-4317 | In distribution | |
| F8014-0345 | In distribution | |
| F8226-4315 | In distribution | |
| F8226-4310 | In distribution | |
| F8014-0591 | In distribution | |
| F8014-0238 | In distribution | |
| F8014-0458 | In distribution | |
| F8014-0369 | In distribution | |
| F8225-4010 | In distribution | |
| F8224-4320 | In distribution | |
| F8225-4315 | In distribution | |
| F8225-4322 | In distribution | |
| F8227-4318 | In distribution | |
| F8014-0470 | In distribution | |
| F8014-0124 | In distribution | |
| F8014-0232 | In distribution | |
| F8014-0108 | In distribution | |
| F8014-0351 | In distribution | |
| F8226-4318 | In distribution | |
| F8014-0336 | In distribution | |
| F8014-0126 | In distribution | |
| F8226-4011 | In distribution | |
| F8226-4316 | In distribution | |
| F8227-4313 | In distribution | |
| F8224-4012 | In distribution | |
| F8226-4317 | In distribution | |
| F8224-4017 | In distribution | |
| F8227-4013 | In distribution | |
| F8227-4014 | In distribution | |
| F8225-4014 | In distribution | |
| F8225-4314 | In distribution | |
| F8014-0230 | In distribution | |
| F8014-0122 | In distribution | |
| F8225-4316 | In distribution | |
| F8227-4316 | In distribution | |
| F8014-0339 | In distribution | |
| F8226-4016 | In distribution | |
| F8225-4310 | In distribution | |
| F8226-4015 | In distribution | |
| F8227-4311 | In distribution | |
| F8226-4012 | In distribution | |
| F8224-4011 | In distribution | |
| F8014-0363 | In distribution | |
| F8227-4322 | In distribution | |
| F8226-4020 | In distribution | |
| F8225-4311 | In distribution | |
| F8227-4018 | In distribution | |
| F8014-0228 | In distribution | |
| F8014-0576 | In distribution | |
| F8014-0586 | In distribution | |
| F8014-0342 | In distribution | |
| F8225-4016 | In distribution | |
| F8226-4319 | In distribution | |
| F8224-4315 | In distribution | |
| F8014-0360 | In distribution | |
| F8226-4013 | In distribution | |
| F8014-0118 | In distribution | |
| F8224-4311 | In distribution | |
| F8225-4020 | In distribution | |
| F8224-4322 | In distribution | |
| F8227-4320 | In distribution | |
| F8225-4312 | In distribution | |
| F8224-4316 | In distribution | |
| F8014-0244 | In distribution | |
| F8226-4312 | In distribution | |
| F8224-4314 | In distribution | |
| F8224-4020 | In distribution | |
| F8224-4014 | In distribution | |
| F8225-4015 | In distribution | |
| F8224-4317 | In distribution | |
| F8014-0446 | In distribution | |
| F8226-4320 | In distribution | |
| F8224-4019 | In distribution | |
| F8224-4018 | In distribution | |
| F8014-0450 | In distribution | |
| F8225-4013 | In distribution | |
| F8224-4010 | In distribution | |
| F8225-4319 | In distribution | |
| F8014-0462 | In distribution | |
| F8014-0112 | In distribution | |
| F8227-4019 | 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.