Apex-DL Spine System

APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 50mm, Self-Tapping

Registry build 21.09.26
7manufacturers in China registered for this device type
691catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OSH
Manufacturer City Province Registered as Device types
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
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
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34

Record

Regulatory record for Apex-DL Spine System
Listed by Spinecraft LLC, United States
FDA product code OSH
Device type Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device class Class 2
Regulation 21 CFR 888.3070
Establishment Specification developer, Manufacturer
Record published 2019-03-27
Record revised 2024-09-11 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number
Distribution end date 2024-09-01

Catalogue Numbers

Catalogue numbers for Apex-DL Spine System
Catalogue number Size Status
DPF6-10045 In distribution
DMF6-5580C In distribution
DUF6-4780C In distribution
DUF6-7040 In distribution
DPF6-8550 In distribution
DM6-6250 In distribution
DPF6-9270C In distribution
DPR6-7090C In distribution
DMF6-6270C In distribution
DPR6-7745 In distribution
DP6-4735C In distribution
DM6-6255C In distribution
DMF6-5565 In distribution
DU6-4775C In distribution
DP6-6230C In distribution
DM6-5550 In distribution
DU6-8535 In distribution
DP6-7050 In distribution
DP6-6285C In distribution
DPR6-7060C In distribution
DUR6-6280C In distribution
DUF6-7030 In distribution
DMF6-92100C In distribution
DMR6-4755C-F In distribution
DMR6-5575C In distribution
DUF6-5560C In distribution
DMR6-8560-F In distribution
DMR6-7060 In distribution
DPR6-8535-F In distribution
DPR6-6260 In distribution
DU6-4740 In distribution
DMR6-4730-F In distribution
DMF6-10060C In distribution
DUF6-7025C In distribution
DPF6-77100 In distribution
DUF6-8550 In distribution
DMR6-6240 In distribution
DM6-4725 In distribution
DM6-4760 In distribution
DU6-7790 In distribution
DU6-70100 In distribution
DUF6-8535C In distribution
DMR6-5575 In distribution
DM6-10080C In distribution
DMR6-8555C In distribution
DPF6-4765C In distribution
DMR6-8535C-F In distribution
DPF6-7045 In distribution
DPR6-4780-F In distribution
DM6-6265C In distribution
DP6-7035 In distribution
DUR6-5585C In distribution
DUR6-7045-F In distribution
DPF6-6240C In distribution
DMF6-5575C In distribution
DPR6-7780C-F In distribution
DUF6-4745 In distribution
DPF6-9230 In distribution
DM6-7035C In distribution
DP6-10035C In distribution
DPR6-7025-F In distribution
DMR6-6270-F In distribution
DMF6-8555 In distribution
DPF6-8525C In distribution
DU6-7760C In distribution
DPR6-6245C-F In distribution
DUF6-6275C In distribution
DMF6-6275 In distribution
DP6-6260C In distribution
DM6-8525 In distribution
DPF6-4780 In distribution
DU6-4765 In distribution
DMF6-7770C In distribution
DMR6-8540C-F In distribution
DPR6-7055C In distribution
DMF6-9250 In distribution
DP6-6225C In distribution
DPF6-9240C In distribution
DM6-9260 In distribution
DP6-7090 In distribution
DMR6-8525-F In distribution
DM6-8535 In distribution
DPF6-7735 In distribution
DP6-7770C In distribution
DU6-4745 In distribution
DMF6-7090 In distribution
DUR6-4755C In distribution
DMR6-8570-F In distribution
DPR6-5570 In distribution
DUR6-5570 In distribution
DMR6-8525C In distribution
DPF6-8580C In distribution
DPF6-7050C In distribution
DM6-8580 In distribution
DPF6-8530-XL In distribution
DPR6-4770C-F In distribution
DMF6-7060 In distribution
DPR6-5580C In distribution
DMF6-10040C In distribution
DPF6-6285C In distribution
DPR6-7040C-F In distribution
DMR6-7735 In distribution
DPF6-8555 In distribution
DU6-6260 In distribution
DUF6-7745C In distribution
DUF6-7760C In distribution
DP6-8550C In distribution
DU6-7035 In distribution
DUR6-6280 In distribution
DMR6-6235C In distribution
DUF6-8580C In distribution
DMR6-77100-F In distribution
DU6-7045 In distribution
DPF6-7770 In distribution
DPR6-7070-F In distribution
DP6-8580 In distribution
DPR6-7780C In distribution
DU6-4775 In distribution
DMR6-6250-F In distribution
DPR6-7070C-F In distribution
DMF6-10040 In distribution
DM6-4780C In distribution
DUF6-7045 In distribution
DPR6-6235C In distribution
DU6-7740 In distribution
DUR6-4755-F In distribution
DP6-4755C In distribution
DPF6-8540-XL In distribution
DMF6-4725 In distribution
DMF6-5560 In distribution
DUF6-5570 In distribution
DUR6-4785-F In distribution
DUR6-6260C In distribution
DMR6-4740 In distribution
DP6-9290 In distribution
DMR6-4730C-F In distribution
DUR6-5545C In distribution
DU6-6250C In distribution
DM6-6270 In distribution
DMR6-4735C In distribution
DPF6-7770C In distribution
DP6-7735 In distribution
DPR6-5570C In distribution
DU6-7090 In distribution
DPR6-5560C In distribution
DMF6-5585 In distribution
DUR6-4740C In distribution
DUR6-7050C-F In distribution
DPF6-8540C In distribution
DPF6-4740C In distribution
DUF6-6225 In distribution
DPF6-7025 In distribution
DMF6-7025 In distribution
DMR6-6275-F In distribution
DUR6-7080 In distribution
DUR6-5565-F In distribution
DP6-9260C In distribution
DUF6-7060C In distribution
DPR6-4740C-F In distribution
DPF6-6285 In distribution
DM6-8545 In distribution
DMR6-7040 In distribution
DU6-7045C In distribution
DUF6-7050C In distribution
DM6-5540 In distribution
DPR6-5525 In distribution
DUR6-5560 In distribution
DM6-7730C In distribution
DP6-4780 In distribution
DPF6-7080C In distribution
DMF6-9225C In distribution
DMF6-6255 In distribution
DPR6-5555C In distribution
DM6-8530 In distribution
DP6-7070C In distribution
DUF6-7750 In distribution
DMR6-5560C In distribution
DM6-92100 In distribution
DP6-9240C In distribution
DUF6-7730 In distribution
DMF6-8580 In distribution
DMF6-7770 In distribution
DP6-6250C In distribution
DMF6-9280 In distribution
DPR6-5540-F In distribution
DM6-9230C In distribution
DMR6-5525C-F In distribution
DMR6-4755C In distribution
DMF6-8555C In distribution
DMF6-5565C In distribution
DUR6-6260-F In distribution
DMF6-5555 In distribution
DPF610055C In distribution
DMF6-8545 In distribution
DMF6-4770 In distribution
DPR6-7080C In distribution
DP6-100100C In distribution
DUR6-5540C In distribution
DPF6-5560 In distribution
DPF6-7050 In distribution
DM6-10080 In distribution
DP6-10025C In distribution
DUF6-8570C In distribution
DP6-5570C In distribution
DPR6-7040-F In distribution
DU6-8545 In distribution
DPR6-7760C In distribution
DM6-4775C In distribution
DMR6-4780C-F In distribution
DU6-5530 In distribution
DMR6-7790C In distribution
DPR6-7750C-F In distribution
DU6-4760C In distribution
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DM6-7050 In distribution
DMF6-8570 In distribution
DU6-7090C In distribution
DPR6-8570C In distribution
DP6-7740 In distribution
DUF6-8540 In distribution
DPF6-10070 In distribution
DMF6-77100 In distribution
DUR6-6270-F In distribution
DPR6-6265C In distribution
DP6-9235C In distribution
DMR6-8540 In distribution
DMF6-4730 In distribution
DPR6-6275C-F In distribution
DP6-6245C In distribution
DUR6-7055 In distribution
DUR6-5540-F In distribution
DMF6-5540 In distribution
DUR6-5560-F In distribution
DMR6-6280-F In distribution
DPR6-8570-F In distribution
DU6-5570C In distribution
DMF6-4775 In distribution
DUR6-7045C In distribution
DP6-6280C In distribution
DPR6-6250C-F In distribution
DPR6-8535C-F In distribution
DMF6-7740 In distribution
DU6-6285C In distribution
DPF6-4770 In distribution
DMR6-70100-F In distribution
DPR6-4780 In distribution
DMR6-7790C-F In distribution
DMR6-8555C-F In distribution
DM6-10060C In distribution
DPR6-5560-F In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Arsenal Alphatec Spine, Inc. 820
Polaris™ 4.75 Spinal System Biomet Spine 413
Expedium Medos International Sàrl 400
Implanet Spine System Implanet 386
Everest® Spinal System VB Spine LLC 299
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Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

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