MaxAn® Anterior Cervical
159 catalogue numbers from 14-521640BE, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
159catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Biomet Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2020-06-24 |
| Record revised | 2025-07-02 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-521640BE | 4.5 x 10 mm Blunt Variable Screw | In distribution |
| 14-521540BE | 4.5 mm x 10 mm Blunt Fixed Screw | In distribution |
| 14-522456E | 4 Level 56 mm Fixed Plate | In distribution |
| 14-522130E | 1 Level 30 mm Fixed Plate | In distribution |
| 14-522460E | 4 Level 60 mm Fixed Plate | In distribution |
| 14-521656BE | 4.5 x 26 mm Blunt Variable Screw | In distribution |
| 14-521654BE | 4.5 x 24 mm Blunt Variable Screw | In distribution |
| 14-521516BE | 4.0 mm x 16 mm Blunt Fixed Screw | In distribution |
| 14-522226E | 2 Level 26 mm Fixed Plate | In distribution |
| 14-521610E | 4.0 mm x 10 mm Variable Screw | In distribution |
| 14-522248E | 2 Level 48 mm Fixed Plate | In distribution |
| 14-521608E | 4.0 mm x 8 mm Variable Screw | In distribution |
| 14-521642BE | 4.5 x 12 mm Blunt Variable Screw | In distribution |
| 14-521550E | 4.5 mm x 20 mm Fixed Screw | In distribution |
| 14-522134E | 1 Level 34 mm Fixed Plate | In distribution |
| 14-521554BE | 4.5 mm x 24 mm Blunt Fixed Screw | In distribution |
| 14-521622E | 4.0 mm x 22 mm Variable Screw | In distribution |
| 14-522108E | 1 Level 8 mm Fixed Plate | In distribution |
| 14-521508E | 4.0 mm x 8 mm Fixed Screw | In distribution |
| 14-522240E | 2 Level 40 mm Fixed Plate | In distribution |
| 14-522484E | 4 Level 84 mm Fixed Plate | In distribution |
| 14-521624E | 4.0 mm x 24 mm Variable Screw | In distribution |
| 14-522136E | 1 Level 36 mm Fixed Plate | In distribution |
| 14-521654E | 4.5 mm x 24 mm Variable Screw | In distribution |
| 14-521524BE | 4.0 mm x 24 mm Blunt Fixed Screw | In distribution |
| 14-521614BE | 4.0 x 14 mm Blunt Variable Screw | In distribution |
| 14-521650BE | 4.5 x 20 mm Blunt Variable Screw | In distribution |
| 14-521616E | 4.0 mm x 16 mm Variable Screw | In distribution |
| 14-522122E | 1 Level 22 mm Fixed Plate | In distribution |
| 14-522246E | 2 Level 46 mm Fixed Plate | In distribution |
| 14-521640E | 4.5 mm x 10 mm Variable Screw | In distribution |
| 14-521618BE | 4.0 x 18 mm Blunt Variable Screw | In distribution |
| 14-522348E | 3 Level 48 mm Fixed Plate | In distribution |
| 14-522264E | 2 Level 64 mm Fixed Plate | In distribution |
| 14-522118E | 1 Level 18 mm Fixed Plate | In distribution |
| 14-522120E | 1 Level 20 mm Fixed Plate | In distribution |
| 14-522110E | 1 Level 10 mm Fixed Plate | In distribution |
| 14-521508BE | 4.0 mm x 8 mm Blunt Fixed Screw | In distribution |
| 14-521512E | 4.0 mm x 12 mm Fixed Screw | In distribution |
| 14-522242E | 2 Level 42 mm Fixed Plate | In distribution |
| 14-521614E | 4.0 mm x 14 mm Variable Screw | In distribution |
| 14-522366E | 3 Level 66 mm Fixed Plate | In distribution |
| 14-522378E | 3 Level 75 mm Fixed Plate | In distribution |
| 14-522114E | 1 Level 14 mm Fixed Plate | In distribution |
| 14-522492E | 4 Level 92 mm Fixed Plate | In distribution |
| 14-522360E | 3 Level 60 mm Fixed Plate | In distribution |
| 14-521552BE | 4.5 mm x 22 mm Blunt Fixed Screw | In distribution |
| 14-522387E | 3 Level 87 mm Fixed Plate | In distribution |
| 14-522357E | 3 Level 57 mm Fixed Plate | In distribution |
| 14-522238E | 2 Level 38 mm Fixed Plate | In distribution |
| 14-522220E | 2 Level 20 mm Fixed Plate | In distribution |
| 14-522224E | 2 Level 24 mm Fixed Plate | In distribution |
| 14-522262E | 2 Level 62 mm Fixed Plate | In distribution |
| 14-522504E | 4 Level 104 mm Fixed Plate | In distribution |
| 14-522260E | 2 Level 60 mm Fixed Plate | In distribution |
| 14-521650E | 4.5 mm x 20 mm Variable Screw | In distribution |
| 14-521544E | 4.5 mm x 14 mm Fixed Screw | In distribution |
| 14-521646BE | 4.5 x 16 mm Blunt Variable Screw | In distribution |
| 14-521644BE | 4.5 x 14 mm Blunt Variable Screw | In distribution |
| 14-522236E | 2 Level 36 mm Fixed Plate | In distribution |
| 14-522250E | 2 Level 50 mm Fixed Plate | In distribution |
| 14-521518BE | 4.0 mm x 18 mm Blunt Fixed Screw | In distribution |
| 14-522363E | 3 Level 63 mm Fixed Plate | In distribution |
| 14-521610BE | 4.0 x 10 mm Blunt Variable Screw | In distribution |
| 14-521556BE | 4.5 mm x 26 mm Blunt Fixed Screw | In distribution |
| 14-521526E | 4.0 mm x 26 mm Fixed Screw | In distribution |
| 14-521638E | 4.5 mm x 8 mm Variable Screw | In distribution |
| 14-522112E | 1 Level 12 mm Fixed Plate | In distribution |
| 14-521546BE | 4.5 mm x 16 mm Blunt Fixed Screw | In distribution |
| 14-521642E | 4.5 mm x 12 mm Variable Screw | In distribution |
| 14-521554E | 4.5 mm x 24 mm Fixed Screw | In distribution |
| 14-521646E | 4.5 mm x 16 mm Variable Screw | In distribution |
| 14-522496E | 4 Level 96 mm Fixed Plate | In distribution |
| 14-522390E | 3 Level 90 mm Fixed Plate | In distribution |
| 14-521540E | 4.5 mm x 10 mm Fixed Screw | In distribution |
| 14-521652BE | 4.5 x 22 mm Blunt Variable Screw | In distribution |
| 14-521546E | 4.5 mm x 16 mm Fixed Screw | In distribution |
| 14-521544BE | 4.5 mm x 14 mm Blunt Fixed Screw | In distribution |
| 14-522126E | 1 Level 26 mm Fixed Plate | In distribution |
| 14-521620BE | 4.0 x 20 mm Blunt Variable Screw | In distribution |
| 14-521626E | 4.0 mm x 26 mm Variable Screw | In distribution |
| 14-521656E | 4.5 mm x 26 mm Variable Screw | In distribution |
| 14-522128E | 1 Level 28 mm Fixed Plate | In distribution |
| 14-522244E | 2 Level 44 mm Fixed Plate | In distribution |
| 14-522266E | 2 Level 66 mm Fixed Plate | In distribution |
| 14-521618E | 4.0 mm x 18 mm Variable Screw | In distribution |
| 14-521622BE | 4.0 x 22 mm Blunt Variable Screw | In distribution |
| 14-522109E | 1 Level 9 mm Fixed Plate | In distribution |
| 14-522339E | 3 Level 39 mm Fixed Plate | In distribution |
| 14-521548E | 4.5 mm x 18 mm Fixed Screw | In distribution |
| 14-522230E | 2 Level 30 mm Fixed Plate | In distribution |
| 14-521616BE | 4.0 x 16 mm Blunt Variable Screw | In distribution |
| 14-521648BE | 4.5 x 18 mm Blunt Variable Screw | In distribution |
| 14-522375E | 3 Level 75 mm Fixed Plate | In distribution |
| 14-522124E | 1 Level 24 mm Fixed Plate | In distribution |
| 14-522252E | 2 Level 52 mm Fixed Plate | In distribution |
| 14-521644E | 4.5 mm x 14 mm Variable Screw | In distribution |
| 14-522254E | 2 Level 54 mm Fixed Plate | In distribution |
| 14-521518E | 4.0 mm x 18 mm Fixed Screw | In distribution |
| 14-521516E | 4.0 mm x 16 mm Fixed Screw | In distribution |
| 14-522336E | 3 Level 36 mm Fixed Plate | In distribution |
| 14-522111E | 1 Level 11 mm Fixed Plate | In distribution |
| 14-522500E | 4 Level 100 mm Fixed Plate | In distribution |
| 14-522228E | 2 Level 28 mm Fixed Plate | In distribution |
| 14-521520E | 4.0 mm x 20 mm Fixed Screw | In distribution |
| 14-522258E | 2 Level 58 mm Fixed Plate | In distribution |
| 14-522234E | 2 Level 34 mm Fixed Plate | In distribution |
| 14-522354E | 3 Level 54 mm Fixed Plate | In distribution |
| 14-521514BE | 4.0 mm x 14 mm Blunt Fixed Screw | In distribution |
| 14-521510E | 4.0 mm x 10 mm Fixed Screw | In distribution |
| 14-521526BE | 4.0 mm x 26 mm Blunt Fixed Screw | In distribution |
| 14-521612BE | 4.0 x 12 mm Blunt Variable Screw | In distribution |
| 14-521522E | 4.0 mm x 22 mm Fixed Screw | In distribution |
| 14-522270E | 2 Level 70 mm Fixed Plate | In distribution |
| 14-522345E | 3 Level 45 mm Fixed Plate | In distribution |
| 14-521556E | 4.5 mm x 26 mm Fixed Screw | In distribution |
| 14-521624BE | 4.0 x 24 mm Blunt Variable Screw | In distribution |
| 14-521522BE | 4.0 mm x 22 mm Blunt Fixed Screw | In distribution |
| 14-521512BE | 4.0 mm x 12 mm Blunt Fixed Screw | In distribution |
| 14-521538E | 4.5 mm x 8 mm Fixed Screw | In distribution |
| 14-522113E | 1 Level 13 mm Fixed Plate | In distribution |
| 14-521612E | 4.0 mm x 12 mm Variable Screw | In distribution |
| 14-522464E | 4 Level 64 mm Fixed Plate | In distribution |
| 14-522268E | 2 Level 68 mm Fixed Plate | In distribution |
| 14-522333E | 3 Level 33 mm Fixed Plate | In distribution |
| 14-521550BE | 4.5 mm x 20 mm Blunt Fixed Screw | In distribution |
| 14-522468E | 4 Level 68 mm Fixed Plate | In distribution |
| 14-521510BE | 4.0 mm x 10 mm Blunt Fixed Screw | In distribution |
| 14-521608BE | 4.0 x 8 mm Blunt Variable Screw | In distribution |
| 14-522372E | 3 Level 72 mm Fixed Plate | In distribution |
| 14-522369E | 3 Level 69 mm Fixed Plate | In distribution |
| 14-522132E | 1 Level 32 mm Fixed Plate | In distribution |
| 14-521538BE | 4.5 mm x 8 mm Blunt Fixed Screw | In distribution |
| 14-522488E | 4 Level 88 mm Fixed Plate | In distribution |
| 14-521520BE | 4.0 mm x 20 mm Blunt Fixed Screw | In distribution |
| 14-522256E | 2 Level 56 mm Fixed Plate | In distribution |
| 14-522381E | 3 Level 81 mm Fixed Plate | In distribution |
| 14-522116E | 1 Level 16 mm Fixed Plate | In distribution |
| 14-522384E | 3 Level 84 mm Fixed Plate | In distribution |
| 14-522232E | 2 Level 32 mm Fixed Plate | In distribution |
| 14-522480E | 4 Level 80 mm Fixed Plate | In distribution |
| 14-522222E | 2 Level 22 mm Fixed Plate | In distribution |
| 14-521638BE | 4.5 x 8 mm Blunt Variable Screw | In distribution |
| 14-522452E | 4 Level 52 mm Fixed Plate | In distribution |
| 14-522342E | 3 Level 42 mm Fixed Plate | In distribution |
| 14-522448E | 4 Level 48 mm Fixed Plate | In distribution |
| 14-521620E | 4.0 mm x 20 mm Variable Screw | In distribution |
| 14-521514E | 4.0 mm x 14 mm Fixed Screw | In distribution |
| 14-521652E | 4.5 mm x 22 mm Variable Screw | In distribution |
| 14-522472E | 4 Level 72 mm Fixed Plate | In distribution |
| 14-521524E | 4.0 mm x 24 mm Fixed Screw | In distribution |
| 14-522351E | 3 Level 51 mm Fixed Plate | In distribution |
| 14-521542BE | 4.5 mm x 12 mm Blunt Fixed Screw | In distribution |
| 14-521552E | 4.5 mm x 22 mm Fixed Screw | In distribution |
| 14-522476E | 4 Level 76 mm Fixed Plate | In distribution |
| 14-521542E | 4.5 mm x 12 mm Fixed Screw | In distribution |
| 14-521626BE | 4.0 x 26 mm Blunt Variable Screw | In distribution |
| 14-521648E | 4.5 mm x 18 mm Variable Screw | In distribution |
| 14-521548BE | 4.5 mm x 18 mm Blunt Fixed Screw | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103393 | 2011-02-02 |
| K080646 | 2008-05-02 |
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.