Who else makes this device?

Name: Picasso MIS Spinal System
Brand: Picasso MIS Spinal System

Picasso MIS Spinal System · Orthosis, Spinal Pedicle Fixation → Orthopedic

13manufacturers in China registered for this device type

73catalogue 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.

Chinese manufacturers registered for FDA product code MNI
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

Regulatory record for Picasso MIS Spinal System
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)	K120714
Record published	2016-03-07
Record revised	2026-02-25 (version 8)

Specifications

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 numbers for Picasso MIS Spinal System
Catalogue number	Size	Status
016.6160		In distribution
016.2100		In distribution
016.3040		In distribution
016.3035		In distribution
016.2095		In distribution
016.6060		In distribution
016.2080		In distribution
016.3140		In distribution
016.3085		In distribution
016.3065		In distribution
016.2070		In distribution
016.6110		In distribution
016.6035		In distribution
016.3095		In distribution
016.1574		In distribution
016.3110		In distribution
016.1001		In distribution
016.6100		In distribution
016.2040		In distribution
016.6120		In distribution
016.2110		In distribution
016.2120		In distribution
016.2045		In distribution
016.3060		In distribution
016.3075		In distribution
016.2140		In distribution
016.2050		In distribution
016.1562		In distribution
016.6090		In distribution
016.3100		In distribution
016.2130		In distribution
016.6080		In distribution
016.6075		In distribution
016.2055		In distribution
016.1571		In distribution
016.1553		In distribution
016.3070		In distribution
016.3090		In distribution
016.2065		In distribution
016.1554		In distribution
016.3045		In distribution
016.1563		In distribution
016.2075		In distribution
016.1555		In distribution
016.1556		In distribution
016.1552		In distribution
016.6200		In distribution
016.3130		In distribution
016.2035		In distribution
016.3055		In distribution
016.6050		In distribution
016.1564		In distribution
016.6065		In distribution
016.3080		In distribution
016.2060		In distribution
016.3120		In distribution
016.3050		In distribution
016.1573		In distribution
016.6070		In distribution
016.1565		In distribution
016.6055		In distribution
016.6140		In distribution
016.2150		In distribution
016.3150		In distribution
016.6130		In distribution
016.1572		In distribution
016.6040		In distribution
016.1561		In distribution
016.2090		In distribution
016.6045		In distribution
016.6150		In distribution
016.2085		In distribution
016.1551		In distribution

Same Product Code

Other products under the same FDA 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.

Recalls referencing this product code
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.

Picasso MIS Spinal System