Picasso II MIS Spinal System
PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L35mm
13manufacturers in China registered for this device type
67catalogue numbers in this listing
1recall
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, Spinal Pedicle Fixation
Record
| Listed by | CTL Medical Corporation, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K140219 |
| Record published | 2016-03-07 |
| Record revised | 2026-03-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 019.1561 | D6.5 | In distribution |
| 019.8710 | In distribution | |
| 019.1571 | D7.5 | In distribution |
| 119.1790 | In distribution | |
| 019.1870 | In distribution | |
| 119.1780 | In distribution | |
| 019.1010 | In distribution | |
| 119.1760 | In distribution | |
| 119.1845 | In distribution | |
| 119.1870 | In distribution | |
| 119.1775 | In distribution | |
| 019.1554 | D5.5 | In distribution |
| 019.1850 | In distribution | |
| 119.1875 | In distribution | |
| 119.1840 | In distribution | |
| 119.1530 | In distribution | |
| 119.1835 | In distribution | |
| 119.1785 | In distribution | |
| 019.1840 | In distribution | |
| 119.1865 | In distribution | |
| 019.1576 | D7.5 | In distribution |
| 119.1850 | In distribution | |
| 019.1574 | D7.5 | In distribution |
| 119.1730 | In distribution | |
| 019.1855 | In distribution | |
| 019.1875 | In distribution | |
| 119.1630 | In distribution | |
| 019.1556 | D5.5 | In distribution |
| 119.1550 | In distribution | |
| 119.1860 | In distribution | |
| 119.1665 | In distribution | |
| 119.1855 | In distribution | |
| 119.1765 | In distribution | |
| 019.1550 | D5.5 | In distribution |
| 019.1566 | D6.5 | In distribution |
| 019.1860 | In distribution | |
| 119.1560 | In distribution | |
| 019.1551 | D5.5 | In distribution |
| 019.1572 | D7.5 | In distribution |
| 119.1650 | In distribution | |
| 019.1564 | D6.5 | In distribution |
| 019.1885 | In distribution | |
| 019.1575 | D7.5 | In distribution |
| 119.1755 | In distribution | |
| 119.1555 | In distribution | |
| 119.1880 | In distribution | |
| 119.1830 | In distribution | |
| 019.1890 | In distribution | |
| 119.1655 | In distribution | |
| 019.1562 | D6.5 | In distribution |
| 019.1573 | D7.5 | In distribution |
| 119.1660 | In distribution | |
| 019.8175 | In distribution | |
| 019.1565 | D6.5 | In distribution |
| 119.1885 | In distribution | |
| 019.1865 | In distribution | |
| 019.1553 | D5.5 | In distribution |
| 019.1570 | D7.5 | In distribution |
| 119.1565 | In distribution | |
| 019.1560 | D6.5 | In distribution |
| 019.1555 | D5.5 | In distribution |
| 019.1845 | In distribution | |
| 019.1563 | D6.5 | In distribution |
| 019.1552 | D5.5 | In distribution |
| 119.1770 | In distribution | |
| 019.1880 | In distribution | |
| 119.1890 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-07-05 | Class II | Nonconforming Material/Component | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. i | 133 total devices | 2021-04-28 |
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.