Monaco Uni-Planar
Pedicle Screw, Solid, Polyaxial, 5.0mm x 50mm
14manufacturers in China registered for this device type
126catalogue 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) | K211027 |
| Record published | 2023-12-21 |
| Record revised | 2024-09-11 (version 3) |
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 |
|---|---|---|
| 811-5050 | In distribution | |
| 831-1602 | In distribution | |
| 813-8570 | In distribution | |
| 813-8530 | In distribution | |
| 880-5311C | In distribution | |
| 831-1401 | In distribution | |
| 813-9590 | In distribution | |
| 831-1702 | In distribution | |
| 813-9525 | In distribution | |
| 831-1000 | In distribution | |
| 813-6560 | In distribution | |
| 813-7570 | In distribution | |
| 811-5060 | In distribution | |
| 831-1002 | In distribution | |
| 813-6610 | In distribution | |
| 831-1003 | In distribution | |
| 813-5525 | In distribution | |
| 813-9570 | In distribution | |
| 813-7580 | In distribution | |
| 813-9620 | In distribution | |
| 813-4550 | In distribution | |
| 813-6570 | In distribution | |
| 811-5055 | In distribution | |
| 811-6035 | In distribution | |
| 880-5313C | In distribution | |
| 813-6540 | In distribution | |
| 813-6555 | In distribution | |
| 811-6050 | In distribution | |
| 813-9560 | In distribution | |
| 831-1700 | In distribution | |
| 813-4560 | In distribution | |
| 831-1005 | In distribution | |
| 880-6311C | In distribution | |
| 811-6025 | In distribution | |
| 831-1600 | In distribution | |
| 880-6313 | In distribution | |
| 813-8580 | In distribution | |
| 831-1201 | In distribution | |
| 880-6313C | In distribution | |
| 811-5030 | In distribution | |
| 813-5530 | In distribution | |
| 813-7555 | In distribution | |
| 813-5560 | In distribution | |
| 813-5550 | In distribution | |
| 813-4525 | In distribution | |
| 880-6316C | In distribution | |
| 813-7545 | In distribution | |
| 831-1202 | In distribution | |
| 813-8555 | In distribution | |
| 880-5311 | In distribution | |
| 831-1300 | In distribution | |
| 813-9545 | In distribution | |
| 831-1601 | In distribution | |
| 813-5555 | In distribution | |
| 813-6580 | In distribution | |
| 813-6545 | In distribution | |
| 813-6530 | In distribution | |
| 813-8620 | In distribution | |
| 880-5316 | In distribution | |
| 813-8535 | In distribution | |
| 831-1502 | In distribution | |
| 813-9540 | In distribution | |
| 811-5045 | In distribution | |
| 813-7540 | In distribution | |
| 813-6600 | In distribution | |
| 813-9555 | In distribution | |
| 813-7590 | In distribution | |
| 813-7550 | In distribution | |
| 811-5035 | In distribution | |
| 831-1301 | In distribution | |
| 813-6590 | In distribution | |
| 831-1203 | In distribution | |
| 813-9600 | In distribution | |
| 813-4540 | In distribution | |
| 811-6045 | In distribution | |
| 811-5040 | In distribution | |
| 813-7600 | In distribution | |
| 811-6055 | In distribution | |
| 880-5313 | In distribution | |
| 813-6525 | In distribution | |
| 813-9610 | In distribution | |
| 831-1100 | In distribution | |
| 831-1101 | In distribution | |
| 831-1200 | In distribution | |
| 831-1501 | In distribution | |
| 813-9550 | In distribution | |
| 813-8550 | In distribution | |
| 813-7560 | In distribution | |
| 813-9530 | In distribution | |
| 831-1400 | In distribution | |
| 880-5316C | In distribution | |
| 831-1603 | In distribution | |
| 813-7620 | In distribution | |
| 813-7535 | In distribution | |
| 813-7525 | In distribution | |
| 811-5025 | In distribution | |
| 813-8540 | In distribution | |
| 813-5540 | In distribution | |
| 831-1001 | In distribution | |
| 813-6620 | In distribution | |
| 831-1004 | In distribution | |
| 813-8525 | In distribution | |
| 813-4530 | In distribution | |
| 831-1500 | In distribution | |
| 813-4535 | In distribution | |
| 880-6311 | In distribution | |
| 813-5545 | In distribution | |
| 813-7530 | In distribution | |
| 813-9535 | In distribution | |
| 811-6030 | In distribution | |
| 813-5535 | In distribution | |
| 813-8600 | In distribution | |
| 813-7610 | In distribution | |
| 813-8610 | In distribution | |
| 813-8590 | In distribution | |
| 831-1701 | In distribution | |
| 813-6550 | In distribution | |
| 813-8560 | In distribution | |
| 813-8545 | In distribution | |
| 813-6535 | In distribution | |
| 813-4545 | In distribution | |
| 880-6316 | In distribution | |
| 811-6040 | In distribution | |
| 811-6060 | In distribution | |
| 813-4555 | In distribution | |
| 813-9580 | 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.