Orthopedic › ProstheticOrthosis, Spinal Pedicle Fixation

Preference 2

6.0 Slot, Reduction, HF Polyaxial Screw Assembly - Large Headbody, Non-Tapping, ø6.5 x 55mm

Registry build 21.09.26
13manufacturers in China registered for this device type
271catalogue 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.

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 Preference 2
Listed by Sintx Technologies Inc., United States
FDA product code MNI
Device type Orthosis, Spinal Pedicle Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
510(k) K081883
Record published 2017-12-29
Record revised 2026-03-20 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Sizes Length 18 to 600 mm; outer diameter 4.5 to 8.2 mm
Distribution end date 2024-11-15

Catalogue Numbers

Catalogue numbers for Preference 2
Catalogue number Size Status
N Length 70 mm In distribution
V Outer Diameter 6 mm In distribution
T Outer Diameter 6 mm In distribution
A Outer Diameter 6 mm In distribution
C Length 22 mm In distribution
V Outer Diameter 6 mm In distribution
T Outer Diameter 6 mm In distribution
D Length 25 mm Withdrawn
B Outer Diameter 8.2 mm Withdrawn
C Length 34 mm Withdrawn
G Length 30 mm Withdrawn
E Length 50 mm Withdrawn
D Length 55 mm Withdrawn
A Length 55 mm Withdrawn
A Withdrawn
B Withdrawn
A Length 40 mm Withdrawn
G Length 35 mm Withdrawn
T Outer Diameter 6 mm Withdrawn
N/A Withdrawn
E Length 30 mm Withdrawn
C Length 35 mm Withdrawn
D Length 35 mm Withdrawn
C Length 55 mm Withdrawn
E Length 50 mm Withdrawn
F Length 40 mm Withdrawn
B Length 50 mm Withdrawn
C Withdrawn
E Outer Diameter 8.2 mm Withdrawn
C Length 35 mm Withdrawn
A Withdrawn
D Length 55 mm Withdrawn
D Withdrawn
A Outer Diameter 6 mm Withdrawn
C Length 50 mm Withdrawn
A Length 60 mm Withdrawn
A Outer Diameter 6 mm Withdrawn
G Outer Diameter 7.2 mm Withdrawn
C Withdrawn
B Length 60 mm Withdrawn
G Length 60 mm Withdrawn
C Length 35 mm Withdrawn
A Length 35 mm Withdrawn
T Outer Diameter 6 mm Withdrawn
P Withdrawn
D Length 55 mm Withdrawn
A Withdrawn
C Length 45 mm Withdrawn
D Withdrawn
B Withdrawn
B Withdrawn
A Length 50 mm Withdrawn
B Withdrawn
E Length 40 mm Withdrawn
B Length 50 mm Withdrawn
A Withdrawn
A Length 30 mm Withdrawn
G Outer Diameter 6.5 mm Withdrawn
A Withdrawn
H Withdrawn
C Withdrawn
G Withdrawn
B Length 40 mm Withdrawn
C Length 50 mm Withdrawn
C Withdrawn
B Length 40 mm Withdrawn
A Length 35 mm Withdrawn
B Length 40 mm Withdrawn
B Length 35 mm Withdrawn
G Length 45 mm Withdrawn
T Outer Diameter 6 mm Withdrawn
A Length 45 mm Withdrawn
B Withdrawn
E Withdrawn
C Withdrawn
D Length 45 mm Withdrawn
G Length 25 mm Withdrawn
A Length 35 mm Withdrawn
H Length 70 mm Withdrawn
A Withdrawn
C Length 40 mm Withdrawn
A Withdrawn
C Length 40 mm Withdrawn
D Length 35 mm Withdrawn
E Length 30 mm Withdrawn
C Length 26 mm Withdrawn
D Withdrawn
E Length 45 mm Withdrawn
C Withdrawn
B Length 30 mm Withdrawn
C Length 30 mm Withdrawn
C Withdrawn
E Length 110 mm Withdrawn
C Length 25 mm Withdrawn
V Outer Diameter 6 mm Withdrawn
D Length 45 mm Withdrawn
A Length 40 mm Withdrawn
C Length 25 mm Withdrawn
E Length 60 mm Withdrawn
D Length 35 mm Withdrawn
N Withdrawn
G Withdrawn
A Length 45 mm Withdrawn
B Length 100 mm Withdrawn
H Outer Diameter 6 mm Withdrawn
B Length 40 mm Withdrawn
A Length 40 mm Withdrawn
B Length 30 mm Withdrawn
B Length 50 mm Withdrawn
C Length 25 mm Withdrawn
E Length 30 mm Withdrawn
C Length 50 mm Withdrawn
H Outer Diameter 6 mm Withdrawn
E Length 90 mm Withdrawn
H Withdrawn
C Length 30 mm Withdrawn
D Withdrawn
V Outer Diameter 6 mm Withdrawn
B Withdrawn
A Length 30 mm Withdrawn
E Length 40 mm Withdrawn
N/A Withdrawn
A Length 45 mm Withdrawn
D Length 45 mm Withdrawn
N/A Withdrawn
G Outer Diameter 5.5 mm Withdrawn
B Length 80 mm Withdrawn
F Withdrawn
E Withdrawn
B Withdrawn
D Length 25 mm Withdrawn
G Length 50 mm Withdrawn
E Length 50 mm Withdrawn
D Length 110 mm Withdrawn
G Outer Diameter 4.5 mm Withdrawn
B Withdrawn
C Length 45 mm Withdrawn
N Outer Diameter 5.5 mm Withdrawn
D Length 55 mm Withdrawn
C Length 25 mm Withdrawn
A Length 55 mm Withdrawn
A Length 35 mm Withdrawn
A Length 25 mm Withdrawn
B Outer Diameter 8.2 mm Withdrawn
G Length 55 mm Withdrawn
B Length 25 mm Withdrawn
F Withdrawn
B Length 55 mm Withdrawn
P Withdrawn
H Outer Diameter 5.5 mm Withdrawn
A Length 40 mm Withdrawn
E Withdrawn
N/A Withdrawn
E Length 45 mm Withdrawn
N Withdrawn
A Length 30 mm Withdrawn
D Length 45 mm Withdrawn
B Withdrawn
A Outer Diameter 5.5 mm Withdrawn
C Length 90 mm Withdrawn
E Length 40 mm Withdrawn
V Outer Diameter 6 mm Withdrawn
E Length 40 mm Withdrawn
B Outer Diameter 8.2 mm Withdrawn
A Withdrawn
C Length 110 mm Withdrawn
D Withdrawn
C Withdrawn
B Length 50 mm Withdrawn
B Length 60 mm Withdrawn
C Length 30 mm Withdrawn
E Length 50 mm Withdrawn
G Outer Diameter 6.5 mm Withdrawn
B Length 25 mm Withdrawn
E Length 100 mm Withdrawn
A Length 45 mm Withdrawn
-01 Withdrawn
B Length 60 mm Withdrawn
B Length 35 mm Withdrawn
K Withdrawn
N/A Withdrawn
B Length 50 mm Withdrawn
G Outer Diameter 6.5 mm Withdrawn
C Length 70 mm Withdrawn
C Length 40 mm Withdrawn
G Outer Diameter 4.5 mm Withdrawn
H Length 45 mm Withdrawn
C Withdrawn
A Length 55 mm Withdrawn
E Length 30 mm Withdrawn
H Length 110 mm Withdrawn
C Length 60 mm Withdrawn
C Length 55 mm Withdrawn
E Length 70 mm Withdrawn
G Outer Diameter 7.2 mm Withdrawn
E Withdrawn
B Length 45 mm Withdrawn
E Length 80 mm Withdrawn
D Length 90 mm Withdrawn
G Outer Diameter 5.5 mm Withdrawn
B Length 18 mm Withdrawn
C Length 45 mm Withdrawn
N/A Withdrawn
G Outer Diameter 7.2 mm Withdrawn
B Withdrawn
G Length 40 mm Withdrawn
B Length 30 mm Withdrawn
E Length 60 mm Withdrawn
G Outer Diameter 6.5 mm Withdrawn
H Length 90 mm Withdrawn
D Withdrawn
B Length 45 mm Withdrawn
C Length 40 mm Withdrawn
B Length 100 mm Withdrawn
B Outer Diameter 8.2 mm Withdrawn
B Outer Diameter 5.5 mm Withdrawn
L Withdrawn
A Length 25 mm Withdrawn
H Length 35 mm Withdrawn
A Withdrawn
A Withdrawn
H Length 55 mm Withdrawn
B Withdrawn
E Length 55 mm Withdrawn
G Outer Diameter 5.5 mm Withdrawn
H Outer Diameter 6 mm Withdrawn
E Length 60 mm Withdrawn
B Length 30 mm Withdrawn
D Length 25 mm Withdrawn
A Length 50 mm Withdrawn
C Length 100 mm Withdrawn
N/A Withdrawn
A Withdrawn
D Length 35 mm Withdrawn
A Length 25 mm Withdrawn
H Withdrawn
F Withdrawn
B Outer Diameter 5.5 mm Withdrawn
N Length 45 mm Withdrawn
G Outer Diameter 5.5 mm Withdrawn
C Length 80 mm Withdrawn
C Length 30 mm Withdrawn
C Length 60 mm Withdrawn
D Length 25 mm Withdrawn
A Length 60 mm Withdrawn
D Withdrawn
A Withdrawn
A Length 30 mm Withdrawn
B Withdrawn
L Withdrawn

Showing 250 of 271 catalogue numbers.

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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer