Picasso MIS Spinal System
Percutaneous Straight Rod, D6.0 x L160mm
13manufacturers in China registered for this device type
52catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | CTL Medical Corporation, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K120714 |
| Record published | 2023-09-06 |
| Record revised | 2026-02-26 (version 8) |
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 |
|---|---|---|
| 016.5190 | In distribution | |
| 016.3040.L | In distribution | |
| 016.3035.L | In distribution | |
| 016.6160.L | In distribution | |
| 016.3070.L | In distribution | |
| 016.6150.L | In distribution | |
| 016.6165.L | In distribution | |
| 016.3100.L | In distribution | |
| 016.5200 | In distribution | |
| 016.6180 | In distribution | |
| 016.3060.L | In distribution | |
| 016.6175.L | In distribution | |
| 016.3120.L | In distribution | |
| 016.6170.L | In distribution | |
| 016.5210 | In distribution | |
| 016.5250 | In distribution | |
| 016.5240 | In distribution | |
| 016.7051 | In distribution | |
| 016.6170 | In distribution | |
| 016.3130.L | In distribution | |
| 016.6185.L | In distribution | |
| 016.3080.L | In distribution | |
| 016.5220 | In distribution | |
| 016.3055.L | In distribution | |
| 016.6085 | In distribution | |
| 016.6190.L | In distribution | |
| 016.3065.L | In distribution | |
| 016.6180.L | In distribution | |
| 016.6140.L | In distribution | |
| 016.6130.L | In distribution | |
| 016.6190 | In distribution | |
| 016.3150.L | In distribution | |
| 016.3110.L | In distribution | |
| 016.6155.L | In distribution | |
| 016.3045.L | In distribution | |
| 016.3085.L | In distribution | |
| 016.6095 | In distribution | |
| 016.5230 | In distribution | |
| 016.6200.L | In distribution | |
| 016.5170 | In distribution | |
| 016.3190 | In distribution | |
| 016.6185 | In distribution | |
| 016.3140.L | In distribution | |
| 016.6155 | In distribution | |
| 016.3090.L | In distribution | |
| 016.3075.L | In distribution | |
| 016.6175 | In distribution | |
| 016.6165 | In distribution | |
| 016.3050.L | In distribution | |
| 016.3095.L | In distribution | |
| 016.5160 | In distribution | |
| 016.5180 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
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.