Admiral
4.3mm Variable Angle Screw, Self-Drilling, 15mm
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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K212139 |
| Record published | 2021-12-23 |
| Record revised | 2025-10-24 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AP1-410084 | In distribution | |
| AP1-714315 | In distribution | |
| AP1-410066 | In distribution | |
| AP1-704011 | In distribution | |
| AP1-734314 | In distribution | |
| AP3-000013 | In distribution | |
| AP1-200026 | In distribution | |
| AP3-110011 | In distribution | |
| AP1-210042 | In distribution | |
| AP1-604018 | In distribution | |
| AP3-100040 | In distribution | |
| AP1-511050 | In distribution | |
| AP1-510775 | In distribution | |
| AP1-550725 | In distribution | |
| AP1-200030 | In distribution | |
| AP1-100008 | In distribution | |
| AP3-000012 | In distribution | |
| AP3-000011 | In distribution | |
| AP1-110028 | In distribution | |
| AP1-614014 | In distribution | |
| AP1-500080 | In distribution | |
| AP1-410078 | In distribution | |
| AP1-724012 | In distribution | |
| AP1-510850 | In distribution | |
| AP1-210052 | In distribution | |
| AP1-724018 | In distribution | |
| AP1-624014 | In distribution | |
| AP1-100032 | In distribution | |
| AP3-120005 | In distribution | |
| AP1-724314 | In distribution | |
| AP2-000125 | In distribution | |
| AP1-400054 | In distribution | |
| AP1-310036 | In distribution | |
| AP1-400058 | In distribution | |
| AP1-410080 | In distribution | |
| AP3-110001 | In distribution | |
| AP1-714318 | In distribution | |
| AP1-510750 | In distribution | |
| AP1-614020 | In distribution | |
| AP1-510875 | In distribution | |
| AP1-551075 | In distribution | |
| AP1-724318 | In distribution | |
| AP1-724021 | In distribution | |
| AP1-604014 | In distribution | |
| AP1-410072 | In distribution | |
| AP1-110026 | In distribution | |
| AP1-550800 | In distribution | |
| AP1-500100 | In distribution | |
| AP1-410076 | In distribution | |
| AP1-734321 | In distribution | |
| AP1-614314 | In distribution | |
| AP1-734015 | In distribution | |
| AP1-714018 | In distribution | |
| AP1-551000 | In distribution | |
| AP1-200044 | In distribution | |
| AP1-734021 | In distribution | |
| AP1-624316 | In distribution | |
| AP1-714017 | In distribution | |
| AP1-410074 | In distribution | |
| AP1-510725 | In distribution | |
| AP1-550925 | In distribution | |
| AP1-704312 | In distribution | |
| AP1-210032 | In distribution | |
| AP1-100016 | In distribution | |
| AP1-310063 | In distribution | |
| AP1-200020 | In distribution | |
| AP1-714321 | In distribution | |
| AP2-000122 | In distribution | |
| AP1-300078 | In distribution | |
| AP3-110043 | In distribution | |
| AP1-724016 | In distribution | |
| AP1-511000 | In distribution | |
| AP1-624012 | In distribution | |
| AP3-000010 | In distribution | |
| AP1-110011 | In distribution | |
| AP1-704013 | In distribution | |
| AP1-300069 | In distribution | |
| AP1-624314 | In distribution | |
| AP1-734019 | In distribution | |
| AP1-734012 | In distribution | |
| AP2-100120 | In distribution | |
| AP1-704014 | In distribution | |
| AP1-450078 | In distribution | |
| AP1-310069 | In distribution | |
| AP1-410058 | In distribution | |
| AP1-110013 | In distribution | |
| AP1-724310 | In distribution | |
| AP1-634020 | In distribution | |
| AP1-200046 | In distribution | |
| AP1-634318 | In distribution | |
| AP1-100010 | In distribution | |
| AP1-200036 | In distribution | |
| AP1-704322 | In distribution | |
| AP1-634314 | In distribution | |
| AP1-450058 | In distribution | |
| AP1-714020 | In distribution | |
| AP1-714015 | In distribution | |
| AP1-714316 | In distribution | |
| AP1-704020 | In distribution | |
| AP1-300054 | In distribution | |
| AP1-704313 | In distribution | |
| AP1-714014 | In distribution | |
| AP1-704019 | In distribution | |
| AP1-724322 | In distribution | |
| AP1-724319 | In distribution | |
| AP1-550975 | In distribution | |
| AP1-714320 | In distribution | |
| AP1-300042 | In distribution | |
| AP1-724313 | In distribution | |
| AP2-000120 | In distribution | |
| AP1-400066 | In distribution | |
| AP1-550700 | In distribution | |
| AP1-634022 | In distribution | |
| AP2-000002 | In distribution | |
| AP1-734322 | In distribution | |
| AP1-510900 | In distribution | |
| AP1-210036 | In distribution | |
| AP1-614318 | In distribution | |
| AP1-734317 | In distribution | |
| AP1-100009 | In distribution | |
| AP1-100028 | In distribution | |
| AP1-310078 | In distribution | |
| AP1-110009 | In distribution | |
| AP1-450050 | In distribution | |
| AP1-100024 | In distribution | |
| AP1-704320 | In distribution | |
| AP1-450086 | In distribution | |
| AP1-200042 | In distribution | |
| AP1-210028 | In distribution | |
| AP1-634012 | In distribution | |
| AP1-704018 | In distribution | |
| AP1-400078 | In distribution | |
| AP1-400074 | In distribution | |
| AP1-724312 | In distribution | |
| AP1-210040 | In distribution | |
| AP1-450072 | In distribution | |
| AP1-604316 | In distribution | |
| AP1-724316 | In distribution | |
| AP1-714317 | In distribution | |
| AP1-704315 | In distribution | |
| AP1-511075 | In distribution | |
| AP1-450090 | In distribution | |
| AP1-550825 | In distribution | |
| AP3-120004 | In distribution | |
| AP1-100012 | In distribution | |
| AP3-110010 | In distribution | |
| AP1-604012 | In distribution | |
| AP1-734316 | In distribution | |
| AP1-200032 | In distribution | |
| AP1-500090 | In distribution | |
| AP1-300039 | In distribution | |
| AP3-100011 | In distribution | |
| AP1-110007 | In distribution | |
| AP1-511100 | In distribution | |
| AP3-100003 | In distribution | |
| AP1-210022 | In distribution | |
| AP1-614016 | In distribution | |
| AP1-604022 | In distribution | |
| AP1-100030 | In distribution | |
| AP1-550850 | In distribution | |
| AP1-200038 | In distribution | |
| AP1-200034 | In distribution | |
| AP1-100022 | In distribution | |
| AP1-724020 | In distribution | |
| AP1-734318 | In distribution | |
| AP1-400070 | In distribution | |
| AP1-624312 | In distribution | |
| AP1-724011 | In distribution | |
| AP3-100002 | In distribution | |
| AP1-210020 | In distribution | |
| AP1-300045 | In distribution | |
| AP1-200050 | In distribution | |
| AP1-510825 | In distribution | |
| AP1-500085 | In distribution | |
| AP1-724013 | In distribution | |
| AP1-624018 | In distribution | |
| AP1-210048 | In distribution | |
| AP3-110002 | In distribution | |
| AP3-210001 | In distribution | |
| AP1-714021 | In distribution | |
| AP1-210026 | In distribution | |
| AP1-400090 | In distribution | |
| AP3-100004 | In distribution | |
| AP1-551100 | In distribution | |
| AP1-604312 | In distribution | |
| AP1-500110 | In distribution | |
| AP1-624010 | In distribution | |
| AP1-734320 | In distribution | |
| AP1-704016 | In distribution | |
| AP1-550775 | In distribution | |
| AP1-724311 | In distribution | |
| AP1-210018 | In distribution | |
| AP1-704319 | In distribution | |
| AP1-110010 | In distribution | |
| AP1-450056 | In distribution | |
| AP1-300066 | In distribution | |
| AP1-634014 | In distribution | |
| AP1-210044 | In distribution | |
| AP1-410086 | In distribution | |
| AP1-410052 | In distribution | |
| AP1-724014 | In distribution | |
| AP1-100014 | In distribution | |
| AP1-624016 | In distribution | |
| AP1-310072 | In distribution | |
| AP1-724010 | In distribution | |
| AP1-704314 | In distribution | |
| AP1-634016 | In distribution | |
| AP1-510950 | In distribution | |
| AP1-734020 | In distribution | |
| AP1-410054 | In distribution | |
| AP1-400082 | In distribution | |
| AP1-400062 | In distribution | |
| AP1-724320 | In distribution | |
| AP3-110003 | In distribution | |
| AP1-550750 | In distribution | |
| AP1-410060 | In distribution | |
| AP1-634316 | In distribution | |
| AP1-310060 | In distribution | |
| AP1-704318 | In distribution | |
| AP1-714314 | In distribution | |
| AP1-450088 | In distribution | |
| AP1-410068 | In distribution | |
| AP1-734018 | In distribution | |
| AP1-550900 | In distribution | |
| AP1-614018 | In distribution | |
| AP1-100018 | In distribution | |
| AP2-100002 | In distribution | |
| AP1-724315 | In distribution | |
| AP1-100015 | In distribution | |
| AP1-500105 | In distribution | |
| AP1-614022 | In distribution | |
| AP1-724022 | In distribution | |
| AP1-604322 | In distribution | |
| AP1-734313 | In distribution | |
| AP1-624310 | In distribution | |
| AP1-450066 | In distribution | |
| AP1-724317 | In distribution | |
| AP1-450074 | In distribution | |
| AP1-310042 | In distribution | |
| AP1-410088 | In distribution | |
| AP1-614320 | In distribution | |
| AP1-714012 | In distribution | |
| AP3-100043 | In distribution | |
| AP1-110015 | In distribution | |
| AP1-300051 | In distribution | |
| AP1-100026 | In distribution | |
| AP1-100020 | In distribution | |
| AP1-510975 | In distribution | |
| AP1-450082 | In distribution | |
| AP1-200040 | In distribution |
Showing 250 of 300 catalogue numbers.
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212139 | 2021-09-01 |
| K211903 | 2021-08-30 |
| K202064 | 2020-08-26 |
| K200885 | 2020-05-28 |
| K173521 | 2018-01-24 |
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.