Orthopedic › ProstheticOrthosis, Spondylolisthesis Spinal Fixation

Inertia® Pedicle Screw System

Polyaxial Pedicle Screw, Ø7.0mm x 100mm

Registry build 21.09.26
13manufacturers in China registered for this device type
185catalogue numbers in this listing
2510(k) clearances naming this product code

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 MNH
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

Regulatory record for Inertia® Pedicle Screw System
Listed by Nexxt Spine LLC, United States
FDA product code MNH
Device type Orthosis, Spondylolisthesis Spinal Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
510(k) K132412
Record published 2015-08-28
Record revised 2023-04-04 (version 7)

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, serial number
Sizes Outer diameter 4.5 to 10.5 mm; length 4.25 to 400 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Inertia® Pedicle Screw System
Catalogue number Size Status
10-14-6530 MIS In distribution
10-30-6540 Outer Diameter 6.5 mm In distribution
10-22-6530 Outer Diameter 6.5 mm In distribution
10-30-8590 Outer Diameter 8.5 mm In distribution
10-17-55100 MIS In distribution
10-17-5560 MIS In distribution
I10-33-20 In distribution
10-15-5555 Length 55 mm In distribution
10-10-6560 Outer Diameter 6.5 mm In distribution
10-20-6545 One Shot In distribution
C10-01-12 In distribution
10-6-55110 Outer Diameter 5.5 mm In distribution
10-14-7035 MIS In distribution
10-14-7535 MIS In distribution
10-10-6535 Outer Diameter 6.5 mm In distribution
10-10-5540 Length 40 mm In distribution
10-14-4540 MIS In distribution
10-20-7560 One Shot In distribution
10-15-5535 Length 35 mm In distribution
10-10-8565 Outer Diameter 8.5 mm In distribution
10-20-7045 One Shot In distribution
10-10-7565 Outer Diameter 7.5 mm In distribution
10-20-7530 One Shot In distribution
10-20-7055 One Shot In distribution
10-10-70100 Outer Diameter 7 mm In distribution
10-7-55140 Outer Diameter 5.5 mm In distribution
C10-01-08 In distribution
I10-33-07 In distribution
10-10-7055 Outer Diameter 7 mm In distribution
10-7-5565 Outer Diameter 5.5 mm In distribution
10-10-5520 Length 20 mm In distribution
10-17-5590 MIS In distribution
10-20-7065 One Shot In distribution
10-10-5555 Outer Diameter 5.5 mm In distribution
10-14-7075 MIS In distribution
10-17-5550 MIS In distribution
10-30-6550 Outer Diameter 6.5 mm In distribution
10-10-7535 Outer Diameter 7.5 mm In distribution
10-10-6570 Outer Diameter 6.5 mm In distribution
10-7-55200 Outer Diameter 5.5 mm In distribution
10-15-7035 Length 35 mm In distribution
10-14-4530 Outer Diameter 4.5 mm In distribution
10-10-5545 Outer Diameter 5.5 mm In distribution
10-14-5535 MIS In distribution
10-10-6540 Length 40 mm In distribution
10-7-5575 Outer Diameter 5.5 mm In distribution
10-10-6590 Outer Diameter 6.5 mm In distribution
10-10-9095 Outer Diameter 9 mm In distribution
10-15-6550 Length 50 mm In distribution
10-10-7090 Outer Diameter 7 mm In distribution
10-6-5585 Outer Diameter 5.5 mm In distribution
10-30-5550 Outer Diameter 5.5 mm In distribution
10-6-5530 Outer Diameter 5.5 mm In distribution
10-22-7540 Outer Diameter 7.5 mm In distribution
10-22-5550 Outer Diameter 5.5 mm In distribution
10-22-5530 Outer Diameter 5.5 mm In distribution
10-20-5740 One Shot In distribution
10-10-6520 Length 20 mm In distribution
10-15-7550 Length 50 mm In distribution
I10-33-05 In distribution
10-17-5535 MIS In distribution
10-30-6530 Outer Diameter 6.5 mm In distribution
C10-02-07 In distribution
10-10-7520 Outer Diameter 7.5 mm In distribution
10-22-6540 Outer Diameter 6.5 mm In distribution
10-7-5585 Outer Diameter 5.5 mm In distribution
10-14-7065 MIS In distribution
10-17-55145 MIS In distribution
10-14-6550 MIS In distribution
10-20-7570 One Shot In distribution
10-15-5525 Length 25 mm In distribution
10-15-7530 Length 30 mm In distribution
10-30-7540 Outer Diameter 7.5 mm In distribution
10-6-5540 Outer Diameter 5.5 mm In distribution
C10-01-13S In distribution
10-14-7525 MIS In distribution
10-10-5525 Length 25 mm In distribution
10-14-7585 MIS In distribution
10-10-7585 Outer Diameter 7.5 mm In distribution
10-10-6580 Outer Diameter 6.5 mm In distribution
10-6-5560 Outer Diameter 5.5 mm In distribution
10-14-6540 MIS In distribution
10-10-8545 Outer Diameter 8.5 mm In distribution
10-14-7565 MIS In distribution
10-17-55175 MIS In distribution
C10-01-09 In distribution
10-20-6730 One Shot In distribution
10-10-5550 Length 50 mm In distribution
10-30-7550 Outer Diameter 7.5 mm In distribution
10-10-7060 Outer Diameter 7 mm In distribution
10-4-001 Outer Diameter 10.5 mm In distribution
10-20-5530 One Shot In distribution
10-15-6540 Length 40 mm In distribution
10-10-7080 Outer Diameter 7 mm In distribution
10-14-5555 MIS In distribution
10-20-6535 One Shot In distribution
10-17-55120 MIS In distribution
10-7-55400 Outer Diameter 5.5 mm In distribution
10-14-7045 MIS In distribution
10-20-5550 One Shot In distribution
I10-02-15 In distribution
10-10-6525 Outer Diameter 6.5 mm In distribution
10-14-4550 MIS In distribution
I10-02-26 Length 254 mm In distribution
10-10-7035 Outer Diameter 7 mm In distribution
10-14-7575 MIS In distribution
10-15-7540 Length 40 mm In distribution
10-10-7555 Outer Diameter 7.5 mm In distribution
10-22-5540 Outer Diameter 5.5 mm In distribution
10-10-8585 Outer Diameter 8.5 mm In distribution
10-30-5530 Outer Diameter 5.5 mm In distribution
C10-01-06 In distribution
10-22-7560 Outer Diameter 7.5 mm In distribution
10-15-7055 Length 55 mm In distribution
10-20-6750 One Shot In distribution
10-22-7040 Outer Diameter 7 mm In distribution
10-20-7540 One Shot In distribution
10-15-6530 Length 30 mm In distribution
10-22-6550 Outer Diameter 6.5 mm In distribution
10-14-5545 MIS In distribution
10-15-5545 Length 45 mm In distribution
10-20-6740 One Shot In distribution
10-6-5550 Outer Diameter 5.5 mm In distribution
10-6-55130 Outer Diameter 5.5 mm In distribution
10-10-5530 Length 30 mm In distribution
10-10-7025 Outer Diameter 7 mm In distribution
I10-35-01 In distribution
10-10-8555 Outer Diameter 8.5 mm In distribution
10-10-8575 Outer Diameter 8.5 mm In distribution
10-22-6560 Outer Diameter 6.5 mm In distribution
10-10-5535 Outer Diameter 5.5 mm In distribution
10-7-5560 Outer Diameter 5.5 mm In distribution
10-15-7025 Length 25 mm In distribution
10-10-6530 Length 30 mm In distribution
10-10-9035 Outer Diameter 9 mm In distribution
10-14-5525 MIS In distribution
10-30-7530 Outer Diameter 7.5 mm In distribution
10-30-5540 Outer Diameter 5.5 mm In distribution
10-22-7550 Outer Diameter 7.5 mm In distribution
10-20-5560 One Shot In distribution
10-17-5580 MIS In distribution
C10-01-15 In distribution
10-10-9055 Outer Diameter 9 mm In distribution
10-20-7550 One Shot In distribution
10-6-5570 Outer Diameter 5.5 mm In distribution
10-20-7035 One Shot In distribution
10-20-6760 One Shot In distribution
I10-33-14 In distribution
10-10-5580 Length 80 mm In distribution
I10-33-16 In distribution
10-10-9045 Outer Diameter 9 mm In distribution
10-7-55100 Outer Diameter 5.5 mm In distribution
10-7-5535 Outer Diameter 5.5 mm In distribution
C10-01-02 In distribution
10-10-7545 Outer Diameter 7.5 mm In distribution
10-10-8535 Outer Diameter 8.5 mm In distribution
10-10-7070 Outer Diameter 7 mm In distribution
10-10-7575 Outer Diameter 7.5 mm In distribution
10-14-7025 MIS In distribution
10-10-6545 Outer Diameter 6.5 mm In distribution
10-20-6555 One Shot In distribution
10-7-5550 Outer Diameter 5.5 mm In distribution
10-20-5540 One Shot In distribution
10-6-55150 Outer Diameter 5.5 mm In distribution
10-15-7045 Length 45 mm In distribution
10-30-8570 Outer Diameter 8.5 mm In distribution
10-10-7595 Outer Diameter 7.5 mm In distribution
10-14-7545 MIS In distribution
10-17-55105 MIS In distribution
10-10-7045 Outer Diameter 7 mm In distribution
10-10-8525 Outer Diameter 8.5 mm In distribution
I10-02-18 In distribution
10-17-5570 MIS In distribution
10-17-55140 MIS In distribution
I10-04-25 In distribution
10-17-5540 MIS In distribution
10-10-6555 Outer Diameter 6.5 mm In distribution
10-7-5595 Outer Diameter 5.5 mm In distribution
10-17-55125 MIS In distribution
10-14-7055 MIS In distribution
10-22-7060 Outer Diameter 7 mm In distribution
I10-33-27 Reduction In distribution
10-14-7555 MIS In distribution
10-7-55120 Outer Diameter 5.5 mm In distribution
10-22-7050 Outer Diameter 7 mm 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. 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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K141376 2014-06-26
K101278 2010-12-20

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