Maxan ONE Anterior Cervical Plate System
312 catalogue numbers from 14-521638BE2, 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
312catalogue 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 | 2015-10-24 |
| Record revised | 2025-07-02 (version 6) |
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 |
|---|---|---|
| 14-521638BE2 | 4.5 X 8MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521516BE1 | 4.0 X 16MM BLUNT FXD SCREW 1PK | In distribution |
| 14-522366E1 | 3 LEVEL – 66MM PLATE | In distribution |
| 14-521620BE2 | 4.0 X 20MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521638E1 | 4.5 X 8MM VAR SCREW 1PK | In distribution |
| 14-521656E2 | 4.5 X 26MM VAR SCREW 2PK | In distribution |
| 14-522351E1 | 3 LEVEL – 51MM PLATE | In distribution |
| 14-522260E1 | 2 LEVEL – 60MM PLATE | In distribution |
| 14-521646E1 | 4.5 X 16MM VAR SCREW 1PK | In distribution |
| 14-522226E1 | 2 LEVEL – 26MM PLATE | In distribution |
| 14-521617E1 | 4.0 X 17MM VAR SCREW 1PK | In distribution |
| 14-522122E1 | 1 LEVEL – 22MM PLATE | In distribution |
| 14-521639E2 | 4.5 X 9MM VAR SCREW 2PK | In distribution |
| 14-521542BE2 | 4.5 X 12MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521538BE2 | 4.5 X 8MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521620BE1 | 4.0 X 20MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521610E1 | 4.0 X 10MM VAR SCREW 1PK | In distribution |
| 14-522468E1 | 4 LEVEL – 68MM PLATE | In distribution |
| 14-521512E2 | 4.0 X 12MM FXD SCREW 2PK | In distribution |
| 14-521615E2 | 4.0 X 15MM VAR SCREW 2PK | In distribution |
| 14-521656BE1 | 4.5 X 26MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521526E1 | 4.0 X 26MM FXD SCREW 1PK | In distribution |
| 14-521626E1 | 4.0 X 26MM VAR SCREW 1PK | In distribution |
| 14-522348E1 | 3 LEVEL – 48MM PLATE | In distribution |
| 14-521626BE2 | 4.0 X 26MM BLUNT VAR SCREW 2PK | In distribution |
| 14-522266E1 | 2 LEVEL – 66MM PLATE | In distribution |
| 14-522264E1 | 2 LEVEL – 64MM PLATE | In distribution |
| 14-521649E1 | 4.5 X 19MM VAR SCREW 1PK | In distribution |
| 14-521544BE1 | 4.5 X 14MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521638E2 | 4.5 X 8MM VAR SCREW 2PK | In distribution |
| 14-521654BE1 | 4.5 X 24MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521548BE2 | 4.5 X 18MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521551E2 | 4.5 X 21MM FXD SCREW 2PK | In distribution |
| 14-521508E1 | 4.0 X 8MM FXD SCREW 1PK | In distribution |
| 14-521650E1 | 4.5 X 20MM VAR SCREW 1PK | In distribution |
| 14-522500E1 | 4 LEVEL – 100MM PLATE | In distribution |
| 14-521643E2 | 4.5 X 13MM VAR SCREW 2PK | In distribution |
| 14-522128E1 | 1 LEVEL – 28MM PLATE | In distribution |
| 14-521621E1 | 4.0 X 21MM VAR SCREW 1PK | In distribution |
| 14-521610E2 | 4.0 X 10MM VAR SCREW 2PK | In distribution |
| 14-521543E1 | 4.5 X 13MM FXD SCREW 1PK | In distribution |
| 14-521656BE2 | 4.5 X 26MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521616E1 | 4.0 X 16MM VAR SCREW 1PK | In distribution |
| 14-522114E1 | 1 LEVEL – 14MM PLATE | In distribution |
| 14-522242E1 | 2 LEVEL – 42MM PLATE | In distribution |
| 14-521640E1 | 4.5 X 10MM VAR SCREW 1PK | In distribution |
| 14-521623E1 | 4.0 X 23MM VAR SCREW 1PK | In distribution |
| 14-521556E2 | 4.5 X 26MM FXD SCREW 2PK | In distribution |
| 14-521655E1 | 4.5 X 25MM VAR SCREW 1PK | In distribution |
| 14-521655E2 | 4.5 X 25MM VAR SCREW 2PK | In distribution |
| 14-521614E1 | 4.0 X 14MM VAR SCREW 1PK | In distribution |
| 14-521638BE1 | 4.5 X 8MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521612E1 | 4.0 X 12MM VAR SCREW 1PK | In distribution |
| 14-521556BE1 | 4.5 X 26MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521552E1 | 4.5 X 22MM FXD SCREW 1PK | In distribution |
| 14-521626BE1 | 4.0 X 26MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521546E2 | 4.5 X 16MM FXD SCREW 2PK | In distribution |
| 14-521513E2 | 4.0 X 13MM FXD SCREW 2PK | In distribution |
| 14-521538E2 | 4.5 X 8MM FXD SCREW 2PK | In distribution |
| 14-521620E1 | 4.0 X 20MM VAR SCREW 1PK | In distribution |
| 14-521642E2 | 4.5 X 12MM VAR SCREW 2PK | In distribution |
| 14-521611E1 | 4.0 X 11MM VAR SCREW 1PK | In distribution |
| 14-521522E2 | 4.0 X 22MM FXD SCREW 2PK | In distribution |
| 14-521509E1 | 4.0 X 9MM FXD SCREW 1PK | In distribution |
| 14-521525E2 | 4.0 X 25MM FXD SCREW 2PK | In distribution |
| 14-521624E1 | 4.0 X 24MM VAR SCREW 1PK | In distribution |
| 14-521546BE1 | 4.5 X 16MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521548E1 | 4.5 X 18MM FXD SCREW 1PK | In distribution |
| 14-521550BE1 | 4.5 X 20MM BLUNT FXD SCREW 1PK | In distribution |
| 14-522118E1 | 1 LEVEL – 18MM PLATE | In distribution |
| 14-521555E1 | 4.5 X 25MM FXD SCREW 1PK | In distribution |
| 14-521646BE2 | 4.5 X 16MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521550E1 | 4.5 X 20MM FXD SCREW 1PK | In distribution |
| 14-521619E1 | 4.0 X 19MM VAR SCREW 1PK | In distribution |
| 14-521617E2 | 4.0 X 17MM VAR SCREW 2PK | In distribution |
| 14-521614BE2 | 4.0 X 14MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521518BE2 | 4.0 X 18MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521510E2 | 4.0 X 10MM FXD SCREW 2PK | In distribution |
| 14-521609E2 | 4.0 X 9MM VAR SCREW 2PK | In distribution |
| 14-521608BE1 | 4.0 X 8MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521526BE2 | 4.0 X 26MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521550E2 | 4.5 X 20MM FXD SCREW 2PK | In distribution |
| 14-521549E2 | 4.5 X 19MM FXD SCREW 2PK | In distribution |
| 14-522464E1 | 4 LEVEL – 64MM PLATE | In distribution |
| 14-521553E2 | 4.5 X 23MM FXD SCREW 2PK | In distribution |
| 14-521644E1 | 4.5 X 14MM VAR SCREW 1PK | In distribution |
| 14-521545E2 | 4.5 X 15MM FXD SCREW 2PK | In distribution |
| 14-521512BE2 | 4.0 X 12MM BLUNT FXD SCREW 2PK | In distribution |
| 14-522136E1 | 1 LEVEL – 36MM PLATE | In distribution |
| 14-521653E2 | 4.5 X 23MM VAR SCREW 2PK | In distribution |
| 14-522375E1 | 3 LEVEL – 75MM PLATE | In distribution |
| 14-521625E1 | 4.0 X 25MM VAR SCREW 1PK | In distribution |
| 14-522345E1 | 3 LEVEL – 45MM PLATE | In distribution |
| 14-521608E2 | 4.0 X 8MM VAR SCREW 2PK | In distribution |
| 14-522270E1 | 2 LEVEL – 70MM PLATE | In distribution |
| 14-521611E2 | 4.0 X 11MM VAR SCREW 2PK | In distribution |
| 14-521614BE1 | 4.0 X 14MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521654BE2 | 4.5 X 24MM BLUNT VAR SCREW 2PK | In distribution |
| 14-522232E1 | 2 LEVEL – 32MM PLATE | In distribution |
| 14-521544E1 | 4.5 X 14MM FXD SCREW 1PK | In distribution |
| 14-521625E2 | 4.0 X 25MM VAR SCREW 2PK | In distribution |
| 14-521508BE2 | 4.0 X 8MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521618E1 | 4.0 X 18MM VAR SCREW 1PK | In distribution |
| 14-521554BE2 | 4.5 X 24MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521550BE2 | 4.5 X 20MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521626E2 | 4.0 X 26MM VAR SCREW 2PK | In distribution |
| 14-521648E1 | 4.5 X 18MM VAR SCREW 1PK | In distribution |
| 14-521520E2 | 4.0 X 20MM FXD SCREW 2PK | In distribution |
| 14-522387E1 | 3 LEVEL – 87MM PLATE | In distribution |
| 14-521612E2 | 4.0 X 12MM VAR SCREW 2PK | In distribution |
| 14-521653E1 | 4.5 X 23MM VAR SCREW 1PK | In distribution |
| 14-522496E1 | 4 LEVEL – 96MM PLATE | In distribution |
| 14-522246E1 | 2 LEVEL – 46MM PLATE | In distribution |
| 14-522238E1 | 2 LEVEL – 38MM PLATE | In distribution |
| 14-521540BE2 | 4.5 X 10MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521523E1 | 4.0 X 23MM FXD SCREW 1PK | In distribution |
| 14-521622E2 | 4.0 X 22MM VAR SCREW 2PK | In distribution |
| 14-522124E1 | 1 LEVEL – 24MM PLATE | In distribution |
| 14-522488E1 | 4 LEVEL – 88MM PLATE | In distribution |
| 14-522504E1 | 4 LEVEL – 104MM PLATE | In distribution |
| 14-521622BE1 | 4.0 X 22MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521645E2 | 4.5 X 15MM VAR SCREW 2PK | In distribution |
| 14-522480E1 | 4 LEVEL – 80MM PLATE | In distribution |
| 14-522132E1 | 1 LEVEL – 32MM PLATE | In distribution |
| 14-522357E1 | 3 LEVEL – 57MM PLATE | In distribution |
| 14-522112E1 | 1 LEVEL – 12MM PLATE | In distribution |
| 14-521608E1 | 4.0 X 8MM VAR SCREW 1PK | In distribution |
| 14-521510E1 | 4.0 X 10MM FXD SCREW 1PK | In distribution |
| 14-521652E2 | 4.5 X 22MM VAR SCREW 2PK | In distribution |
| 14-522234E1 | 2 LEVEL – 34MM PLATE | In distribution |
| 14-521608BE2 | 4.0 X 8MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521525E1 | 4.0 X 25MM FXD SCREW 1PK | In distribution |
| 14-521538BE1 | 4.5 X 8MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521516BE2 | 4.0 X 16MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521515E1 | 4.0 X 15MM FXD SCREW 1PK | In distribution |
| 14-521539E2 | 4.5 X 9MM FXD SCREW 2PK | In distribution |
| 14-521544E2 | 4.5 X 14MM FXD SCREW 2PK | In distribution |
| 14-522339E1 | 3 LEVEL – 39MM PLATE | In distribution |
| 14-521624BE1 | 4.0 X 24MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521539E1 | 4.5 X 9MM FXD SCREW 1PK | In distribution |
| 14-521542E2 | 4.5 X 12MM FXD SCREW 2PK | In distribution |
| 14-521526E2 | 4.0 X 26MM FXD SCREW 2PK | In distribution |
| 14-522354E1 | 3 LEVEL – 54MM PLATE | In distribution |
| 14-521554E1 | 4.5 X 24MM FXD SCREW 1PK | In distribution |
| 14-521546BE2 | 4.5 X 16MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521524E2 | 4.0 X 24MM FXD SCREW 2PK | In distribution |
| 14-521654E2 | 4.5 X 24MM VAR SCREW 2PK | In distribution |
| 14-521553E1 | 4.5 X 23MM FXD SCREW 1PK | In distribution |
| 14-521647E2 | 4.5 X 17MM VAR SCREW 2PK | In distribution |
| 14-521508E2 | 4.0 X 8MM FXD SCREW 2PK | In distribution |
| 14-521620E2 | 4.0 X 20MM VAR SCREW 2PK | In distribution |
| 14-521510BE2 | 4.0 X 10MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521648BE1 | 4.5 X 18MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521610BE1 | 4.0 X 10MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521650BE2 | 4.5 X 20MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521540BE1 | 4.5 X 10MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521552BE2 | 4.5 X 22MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521644BE1 | 4.5 X 14MM BLUNT VAR SCREW 1PK | In distribution |
| 14-522384E1 | 3 LEVEL – 84MM PLATE | In distribution |
| 14-522342E1 | 3 LEVEL – 42MM PLATE | In distribution |
| 14-521520E1 | 4.0 X 20MM FXD SCREW 1PK | In distribution |
| 14-521520BE2 | 4.0 X 20MM BLUNT FXD SCREW 2PK | In distribution |
| 14-522268E1 | 2 LEVEL – 68MM PLATE | In distribution |
| 14-521652E1 | 4.5 X 22MM VAR SCREW 1PK | In distribution |
| 14-522244E1 | 2 LEVEL – 44MM PLATE | In distribution |
| 14-521513E1 | 4.0 X 13MM FXD SCREW 1PK | In distribution |
| 14-521516E2 | 4.0 X 16MM FXD SCREW 2PK | In distribution |
| 14-522220E1 | 2 LEVEL – 20MM PLATE | In distribution |
| 14-521640E2 | 4.5 X 10MM VAR SCREW 2PK | In distribution |
| 14-522262E1 | 2 LEVEL – 62MM PLATE | In distribution |
| 14-521624E2 | 4.0 X 24MM VAR SCREW 2PK | In distribution |
| 14-521640BE2 | 4.5 X 10MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521522BE2 | 4.0 X 22MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521551E1 | 4.5 X 21MM FXD SCREW 1PK | In distribution |
| 14-522484E1 | 4 LEVEL – 84MM PLATE | In distribution |
| 14-522113E1 | 1 LEVEL – 13MM PLATE | In distribution |
| 14-522381E1 | 3 LEVEL – 81MM PLATE | In distribution |
| 14-521646E2 | 4.5 X 16MM VAR SCREW 2PK | In distribution |
| 14-521549E1 | 4.5 X 19MM FXD SCREW 1PK | In distribution |
| 14-522110E1 | 1 LEVEL – 10MM PLATE | In distribution |
| 14-521609E1 | 4.0 X 9MM VAR SCREW 1PK | In distribution |
| 14-521646BE1 | 4.5 X 16MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521656E1 | 4.5 X 26MM VAR SCREW 1PK | In distribution |
| 14-521619E2 | 4.0 X 19MM VAR SCREW 2PK | In distribution |
| 14-521613E2 | 4.0 X 13MM VAR SCREW 2PK | In distribution |
| 14-521514BE2 | 4.0 X 14MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521544BE2 | 4.5 X 14MM BLUNT FXD SCREW 2PK | In distribution |
| 14-521548BE1 | 4.5 X 18MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521547E2 | 4.5 X 17MM FXD SCREW 2PK | In distribution |
| 14-521644E2 | 4.5 X 14MM VAR SCREW 2PK | In distribution |
| 14-522258E1 | 2 LEVEL – 58MM PLATE | In distribution |
| 14-521518E2 | 4.0 X 18MM FXD SCREW 2PK | In distribution |
| 14-522372E1 | 3 LEVEL – 72MM PLATE | In distribution |
| 14-521640BE1 | 4.5 X 10MM BLUNT VAR SCREW 1PK | In distribution |
| 14-522109E1 | 1 LEVEL – 9MM PLATE | In distribution |
| 14-521642BE1 | 4.5 X 12MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521623E2 | 4.0 X 23MM VAR SCREW 2PK | In distribution |
| 14-522248E1 | 2 LEVEL – 48MM PLATE | In distribution |
| 14-521612BE2 | 4.0 X 12MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521512BE1 | 4.0 X 12MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521518BE1 | 4.0 X 18MM BLUNT FXD SCREW 1PK | In distribution |
| 14-522116E1 | 1 LEVEL – 16MM PLATE | In distribution |
| 14-521618BE1 | 4.0 X 18MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521639E1 | 4.5 X 9MM VAR SCREW 1PK | In distribution |
| 14-522115E1 | 1 LEVEL – 15MM PLATE | In distribution |
| 14-521517E2 | 4.0 X 17MM FXD SCREW 2PK | In distribution |
| 14-521509E2 | 4.0 X 9MM FXD SCREW 2PK | In distribution |
| 14-521648BE2 | 4.5 X 18MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521649E2 | 4.5 X 19MM VAR SCREW 2PK | In distribution |
| 14-521614E2 | 4.0 X 14MM VAR SCREW 2PK | In distribution |
| 14-521512E1 | 4.0 X 12MM FXD SCREW 1PK | In distribution |
| 14-522472E1 | 4 LEVEL – 72MM PLATE | In distribution |
| 14-521510BE1 | 4.0 X 10MM BLUNT FXD SCREW 1PK | In distribution |
| 14-522250E1 | 2 LEVEL – 50MM PLATE | In distribution |
| 14-521541E1 | 4.5 X 11MM FXD SCREW 1PK | In distribution |
| 14-521543E2 | 4.5 X 13MM FXD SCREW 2PK | In distribution |
| 14-521652BE1 | 4.5 X 22MM BLUNT VAR SCREW 1PK | In distribution |
| 14-521610BE2 | 4.0 X 10MM BLUNT VAR SCREW 2PK | In distribution |
| 14-522333E1 | 3 LEVEL – 33MM PLATE | In distribution |
| 14-521641E2 | 4.5 X 11MM VAR SCREW 2PK | In distribution |
| 14-521522E1 | 4.0 X 22MM FXD SCREW 1PK | In distribution |
| 14-521621E2 | 4.0 X 21MM VAR SCREW 2PK | In distribution |
| 14-522120E1 | 1 LEVEL – 20MM PLATE | In distribution |
| 14-521516E1 | 4.0 X 16MM FXD SCREW 1PK | In distribution |
| 14-522252E1 | 2 LEVEL – 52MM PLATE | In distribution |
| 14-521554E2 | 4.5 X 24MM FXD SCREW 2PK | In distribution |
| 14-522448E1 | 4 LEVEL – 48MM PLATE | In distribution |
| 14-521511E1 | 4.0 X 11MM FXD SCREW 1PK | In distribution |
| 14-521654E1 | 4.5 X 24MM VAR SCREW 1PK | In distribution |
| 14-521514BE1 | 4.0 X 14MM BLUNT FXD SCREW 1PK | In distribution |
| 14-522363E1 | 3 LEVEL – 63MM PLATE | In distribution |
| 14-521545E1 | 4.5 X 15MM FXD SCREW 1PK | In distribution |
| 14-521524BE1 | 4.0 X 24MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521519E2 | 4.0 X 19MM FXD SCREW 2PK | In distribution |
| 14-522336E1 | 3 LEVEL – 36MM PLATE | In distribution |
| 14-521652BE2 | 4.5 X 22MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521552BE1 | 4.5 X 22MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521645E1 | 4.5 X 15MM VAR SCREW 1PK | In distribution |
| 14-521648E2 | 4.5 X 18MM VAR SCREW 2PK | In distribution |
| 14-521642BE2 | 4.5 X 12MM BLUNT VAR SCREW 2PK | In distribution |
| 14-521650E2 | 4.5 X 20MM VAR SCREW 2PK | In distribution |
| 14-522476E1 | 4 LEVEL – 76MM PLATE | In distribution |
| 14-522108E1 | 1 LEVEL – 8MM PLATE | In distribution |
| 14-521508BE1 | 4.0 X 8MM BLUNT FXD SCREW 1PK | In distribution |
| 14-521538E1 | 4.5 X 8MM FXD SCREW 1PK | In distribution |
| 14-522256E1 | 2 LEVEL – 56MM PLATE | In distribution |
| 14-521518E1 | 4.0 X 18MM FXD SCREW 1PK | In distribution |
| 14-522369E1 | 3 LEVEL – 69MM PLATE | In distribution |
| 14-522492E1 | 4 LEVEL – 92MM PLATE | In distribution |
| 14-521616BE2 | 4.0 X 16MM BLUNT VAR SCREW 2PK | 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 |
|---|---|
| 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.