Who else makes this device?

Name: M.u.s.t. Polyaxial Pedicle Screw
Brand: M.u.s.t. Polyaxial Pedicle Screw

M.u.s.t. Polyaxial Pedicle Screw · Orthosis, Spinal Pedicle Fixation → Orthopedic

13manufacturers in China registered for this device type

88catalogue numbers in this listing

1510(k) clearance

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 M.u.s.t. Polyaxial Pedicle Screw
Listed by	Medacta International SA, Switzerland
FDA product code	MNI
Device type	Orthosis, Spinal Pedicle Fixation
Device class	Class 2
Regulation	21 CFR 888.3070
Establishment	Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
510(k)	K121115
Record published	2014-09-17
Record revised	2024-10-01 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for M.u.s.t. Polyaxial Pedicle Screw
Catalogue number	Size	Status
03.52.015		In distribution
03.52.011		In distribution
03.52.324		In distribution
03.50.033		In distribution
03.52.313		In distribution
03.52.014		In distribution
03.52.020		In distribution
03.50.002		In distribution
03.50.004		In distribution
03.50.064		In distribution
03.50.090		In distribution
03.50.071		In distribution
03.50.029		In distribution
03.50.083		In distribution
03.50.313		In distribution
03.50.304		In distribution
03.50.031		In distribution
03.50.100		In distribution
03.52.031		In distribution
03.52.342		In distribution
03.52.035		In distribution
03.50.338		In distribution
03.50.058		In distribution
03.50.008		In distribution
03.52.315		In distribution
03.50.102		In distribution
03.50.035		In distribution
03.50.010		In distribution
03.52.009		In distribution
03.50.345		In distribution
03.52.013		In distribution
03.50.056		In distribution
03.52.038		In distribution
03.50.020		In distribution
03.50.073		In distribution
03.50.038		In distribution
03.50.315		In distribution
03.52.328		In distribution
03.52.029		In distribution
03.52.311		In distribution
03.50.050		In distribution
03.50.012		In distribution
03.50.094		In distribution
03.50.096		In distribution
03.50.328		In distribution
03.50.320		In distribution
03.52.336		In distribution
03.52.326		In distribution
03.52.345		In distribution
03.52.022		In distribution
03.50.081		In distribution
03.50.104		In distribution
03.50.006		In distribution
03.50.092		In distribution
03.52.322		In distribution
03.50.005		In distribution
03.50.052		In distribution
03.50.014		In distribution
03.50.342		In distribution
03.52.017		In distribution
03.52.019		In distribution
03.52.340		In distribution
03.50.062		In distribution
03.52.320		In distribution
03.50.322		In distribution
03.50.098		In distribution
03.50.326		In distribution
03.50.022		In distribution
03.52.010		In distribution
03.50.077		In distribution
03.50.003		In distribution
03.50.016		In distribution
03.52.033		In distribution
03.50.302		In distribution
03.50.306		In distribution
03.50.311		In distribution
03.50.336		In distribution
03.52.016		In distribution
03.50.018		In distribution
03.52.018		In distribution
03.50.079		In distribution
03.50.340		In distribution
03.50.060		In distribution
03.52.012		In distribution
03.50.066		In distribution
03.50.324		In distribution
03.52.338		In distribution
03.50.075		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K132788	2014-05-23

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of M.u.s.t. Polyaxial Pedicle Screw
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Medacta Usa Inc	510(k) number	2016-12-07	Class II	Packaging	Damaged packaging, lack of sterility assurance	82 units	2017-11-15

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.

M.u.s.t. Polyaxial Pedicle Screw