Monster Screw System

JOUST Precision Beaming Guidewire Sleeve 2.3mm

Registry build 21.09.26
26manufacturers in China registered for this device type
49catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FZX
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13

Showing 12 of 26. All 26 manufacturers in China registered for Guide, Surgical, Instrument

Record

Regulatory record for Monster Screw System
Listed by Paragon 28, United States
FDA product code FZX
Device type Guide, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-10-17
Record revised 2025-11-19 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Monster Screw System
Catalogue number Size Status
P20-940-4555 In distribution
P26-901-0023 In distribution
P25-931-4500 In distribution
P20-942-4000 In distribution
P20-932-4500 In distribution
P20-944-4000 In distribution
P20-942-3000 In distribution
P25-930-4500 In distribution
P20-944-3500 In distribution
P20-941-3000 In distribution
P26-901-0003 In distribution
P20-940-5055 In distribution
P26-930-7200 In distribution
P26-901-0014 In distribution
P20-932-5000 In distribution
P20-943-4000 In distribution
P20-942-2000 In distribution
P20-941-2025 In distribution
P26-931-5500 In distribution
P26-931-5000 In distribution
P25-930-6200 In distribution
P26-931-7200 In distribution
P26-901-0001-1 In distribution
P25-931-6200 In distribution
P20-931-7000 In distribution
P26-901-0001-2 In distribution
P25-931-5500 In distribution
P26-901-0002 In distribution
P20-943-2700 In distribution
P26-901-0001-3 In distribution
P20-932-7000 In distribution
P20-943-3500 In distribution
P20-941-4000 In distribution
P20-944-2700 In distribution
P20-930-7000 In distribution
P99-900-1005 In distribution
P25-930-GEN1 In distribution
P20-942-2500 In distribution
P26-901-0016 In distribution
P20-932-5500 In distribution
P25-931-4000 In distribution
P20-941-3500 In distribution
P25-930-4000 In distribution
P20-935-7000 In distribution
P25-932-0001 In distribution
P26-901-0004 In distribution
P26-901-0046 In distribution
P25-930-5500 In distribution
P20-942-3500 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DJO Surgical Encore Medical, L.P. 2,141
Guide, Surgical, Instrument Synthes Gmbh 727
DJO Surgical DJO, LLC 284
Apex Knee System Omni Life Science, Inc. 272
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 223
Motoband CP Crossroads Extremity Systems LLC 221
Advance® Microport Orthopedics Inc. 199
NexGen® Zimmer, Inc. 194
Evolution® Microport Orthopedics Inc. 173
Innomed, Inc. Innomed, Inc. 172
Newclip Instruments Newclip Technics SAS 144
Guide, Surgical, Instrument Zimmer, Inc. 135

Showing 12 of 1,788. All products under Guide, Surgical, Instrument

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