Variax

Washer for 1.7mm Bone Screws

Registry build 21.09.26
9manufacturers in China registered for this device type
59catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (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 HTN
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
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Suzhou Endophix Co., Ltd. Suzhou Jiangsu Manufacturer 17

Record

Regulatory record for Variax
Listed by Stryker GmbH, Switzerland
FDA product code HTN
Device type Washer, Bolt Nut
Device class Class 2
Regulation 21 CFR 888.3030
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
510(k) K180500
Record published 2019-10-31
Record revised 2025-04-14 (version 5)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Pack of 5
Sizes Length 6 to 80 mm

Catalogue Numbers

Catalogue numbers for Variax
Catalogue number Size Status
656046 Length 46.0 mm In distribution
657638 Diameter: 2.0 Millimeter In distribution
656170 Diameter: 2.4 Millimeter In distribution
656448 Length 48.0 mm In distribution
657620 Diameter: 2.0 Millimeter In distribution
656007 Length 7.0 mm In distribution
619913M In distribution
657718 Length 18.0 mm In distribution
657715 Diameter: 2.0 Millimeter In distribution
656355 Length 55.0 mm In distribution
657740 Length 40.0 mm In distribution
657606 Diameter: 2.0 Millimeter In distribution
657738 Length 38.0 mm In distribution
656311 Diameter: 2.7 Millimeter In distribution
656109 Diameter: 2.4 Millimeter In distribution
657628 Diameter: 2.0 Millimeter In distribution
656155 Diameter: 2.4 Millimeter In distribution
656315 Diameter: 2.7 Millimeter In distribution
657632 Length 32.0 mm In distribution
657734 Diameter: 2.4 Millimeter In distribution
656175 Length 75.0 mm In distribution
619913 In distribution
656048 Diameter: 2.4 Millimeter In distribution
656013 Diameter: 2.4 Millimeter In distribution
657608 Diameter: 2.0 Millimeter In distribution
656144 Length 44.0 mm In distribution
657709 Diameter: 2.0 Millimeter In distribution
657712 Diameter: 2.0 Millimeter In distribution
656344 Length 44.0 mm In distribution
657724 Length 24.0 mm In distribution
656113 Length 13.0 mm In distribution
619915S In distribution
657713 Length 13.0 mm In distribution
656470 Diameter: 2.7 Millimeter In distribution
656160 Length 60.0 mm In distribution
656060 Diameter: 2.4 Millimeter In distribution
656446 Diameter: 2.7 Millimeter In distribution
656442 Length 42.0 mm In distribution
657716 Diameter: 2.0 Millimeter In distribution
656480 Length 80.0 mm In distribution
619915 In distribution
656146 Diameter: 2.4 Millimeter In distribution
619913S In distribution
656070 Diameter: 2.4 Millimeter In distribution
657630 Diameter: 2.0 Millimeter In distribution
656370 Length 70.0 mm In distribution
657726 Length 26.0 mm In distribution
656415 Length 15.0 mm In distribution
656107 Length 7.0 mm In distribution
656444 Length 44.0 mm In distribution
657736 Diameter: 2.4 Millimeter In distribution
657618 Length 18.0 mm In distribution
619915M In distribution
657609 Length 9.0 mm In distribution
656150 Diameter: 2.4 Millimeter In distribution
657613 Length 13.0 mm In distribution
656009 Length 9.0 mm In distribution
657722 Diameter: 2.0 Millimeter In distribution
657636 Diameter: 2.0 Millimeter In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Washer, Bolt Nut Zimmer, Inc. 308
MaxTorque™ Tornier Inc. 171
Arthrex® Arthrex, Inc. 154
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 92
Washer, Bolt Nut Synthes Gmbh 88
A.l.p.s.® Biomet Orthopedics 67
Conmed ConMed Corporation 38
Neoortho Neoortho Produtos Ortopédicos S/A 32
Aptus Medartis Inc. 31
AC Device Lockdown Medical Limited 31
Evos Smith & Nephew, Inc. 28
Axis Extremity Medical, LLC 26

Showing 12 of 304. All products under Washer, Bolt Nut

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