Monza Cervical Plate System
Self-Drilling Screw, 4.35mm Diameter, Length 18mm
14manufacturers in China registered for this device type
68catalogue 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 | Altus Spine, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K073530 |
| Record published | 2016-10-28 |
| Record revised | 2025-11-20 (version 5) |
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 |
| Sizes | Height 18 to 89 mm; length 12 to 22 mm; outer diameter 4 to 4.3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 135-4018 | Length 18 mm | In distribution |
| 116-0477 | Height 77 mm | In distribution |
| 120-4014 | Outer Diameter 4 mm | In distribution |
| 110-4318 | Length 18 mm | In distribution |
| 116-0253 | Height 53 mm | In distribution |
| 116-0120 | Height 20 mm | In distribution |
| 135-4312 | Length 12 mm | In distribution |
| 116-0474 | Height 74 mm | In distribution |
| 110-4018 | Outer Diameter 4 mm | In distribution |
| 116-0359 | Height 59 mm | In distribution |
| 120-4016 | Length 16 mm | In distribution |
| 135-4014 | Outer Diameter 4 mm | In distribution |
| 116-0489 | Height 89 mm | In distribution |
| 135-4015 | Outer Diameter 4 mm | In distribution |
| 110-4316 | Length 16 mm | In distribution |
| 116-0132 | Height 32 mm | In distribution |
| 116-0486 | Height 86 mm | In distribution |
| 135-4012 | Length 12 mm | In distribution |
| 116-0118 | Height 18 mm | In distribution |
| 116-0365 | Height 65 mm | In distribution |
| 116-0241 | Height 41 mm | In distribution |
| 120-4314 | Outer Diameter 4.3 mm | In distribution |
| 116-0356 | Height 56 mm | In distribution |
| 135-4318 | Length 18 mm | In distribution |
| 135-4316 | Outer Diameter 4.3 mm | In distribution |
| 135-4022 | Outer Diameter 4 mm | In distribution |
| 116-0134 | Height 34 mm | In distribution |
| 116-0238 | Height 38 mm | In distribution |
| 116-0247 | Height 47 mm | In distribution |
| 116-0362 | Height 62 mm | In distribution |
| 116-0250 | Height 50 mm | In distribution |
| 100-1003 | In distribution | |
| 116-0368 | Height 68 mm | In distribution |
| 135-4020 | Outer Diameter 4 mm | In distribution |
| 110-4016 | Outer Diameter 4 mm | In distribution |
| 110-4014 | Outer Diameter 4 mm | In distribution |
| 116-0126 | Height 26 mm | In distribution |
| 116-0256 | Height 56 mm | In distribution |
| 116-0235 | Height 35 mm | In distribution |
| 116-0480 | Height 80 mm | In distribution |
| 135-4013 | Length 13 mm | In distribution |
| 110-4012 | Outer Diameter 4 mm | In distribution |
| 116-0353 | Height 53 mm | In distribution |
| 120-4316 | Outer Diameter 4.3 mm | In distribution |
| 135-4320 | Outer Diameter 4.3 mm | In distribution |
| 120-4318 | Outer Diameter 4.3 mm | In distribution |
| 100-1001 | In distribution | |
| 120-4312 | Length 12 mm | In distribution |
| 135-4016 | Length 16 mm | In distribution |
| 116-0136 | Height 36 mm | In distribution |
| 135-4322 | Length 22 mm | In distribution |
| 110-4314 | Length 14 mm | In distribution |
| 120-4012 | Length 12 mm | In distribution |
| 116-0128 | Height 28 mm | In distribution |
| 116-0350 | Height 50 mm | In distribution |
| 120-4018 | Length 18 mm | In distribution |
| 116-0124 | Height 24 mm | In distribution |
| 116-0377 | Height 77 mm | In distribution |
| 135-4314 | Length 14 mm | In distribution |
| 116-0122 | Height 22 mm | In distribution |
| 100-1022 | In distribution | |
| 116-0371 | Height 71 mm | In distribution |
| 116-0483 | Height 83 mm | In distribution |
| 116-0374 | Height 74 mm | In distribution |
| 116-0244 | Height 44 mm | In distribution |
| 100-1091 | In distribution | |
| 110-4312 | Length 12 mm | In distribution |
| 116-0130 | Height 30 mm | 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.