Autofix

Compression Screw, cannulated

Registry build 21.09.26
31manufacturers in China registered for this device type
82catalogue numbers in this listing
6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWC
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11

Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone

Record

Regulatory record for Autofix
Listed by Stryker GmbH, Switzerland
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Record published 2015-09-24
Record revised 2025-04-14 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Sizes Length 5 to 85 mm

Catalogue Numbers

Catalogue numbers for Autofix
Catalogue number Size Status
141-2017 Diameter: 2.0 Millimeter In distribution
141-4048 Length 48.0 mm In distribution
141-2530 Diameter: 2.5 Millimeter In distribution
141-3032 Diameter: 3.0 Millimeter In distribution
141-3018 Diameter: 3.0 Millimeter In distribution
241-6555 Length 5.0 mm In distribution
141-2528 Diameter: 2.5 Millimeter In distribution
141-2512 Diameter: 2.5 Millimeter In distribution
141-2011 Length 11.0 mm In distribution
141-2511 Diameter: 2.5 Millimeter In distribution
141-4034 Diameter: 4.0 Millimeter In distribution
141-2027 Length 27.0 mm In distribution
141-4036 Diameter: 4.0 Millimeter In distribution
141-2521 Length 21.0 mm In distribution
141-3016 Length 16.0 mm In distribution
141-4032 Diameter: 4.0 Millimeter In distribution
241-6580 Diameter: 6.5 Millimeter In distribution
141-2022 Diameter: 2.0 Millimeter In distribution
141-2510 Length 10.0 mm In distribution
141-2526 Diameter: 2.5 Millimeter In distribution
241-6565 Diameter: 6.5 Millimeter In distribution
141-2513 Diameter: 2.5 Millimeter In distribution
141-4022 Diameter: 4.0 Millimeter In distribution
141-3020 Diameter: 3.0 Millimeter In distribution
141-2520 Length 20.0 mm In distribution
141-3036 Diameter: 3.0 Millimeter In distribution
141-4020 Diameter: 4.0 Millimeter In distribution
141-2019 Diameter: 2.0 Millimeter In distribution
141-2020 Diameter: 2.0 Millimeter In distribution
141-2514 Diameter: 2.5 Millimeter In distribution
141-2018 Length 18.0 mm In distribution
141-2029 Length 29.0 mm In distribution
141-2519 Diameter: 2.5 Millimeter In distribution
141-4030 Diameter: 4.0 Millimeter In distribution
141-2524 Diameter: 2.5 Millimeter In distribution
141-4038 Length 38.0 mm In distribution
141-2014 Length 14.0 mm In distribution
141-2015 Length 15.0 mm In distribution
141-2030 Length 30.0 mm In distribution
141-3022 Diameter: 3.0 Millimeter In distribution
241-6575 Diameter: 6.5 Millimeter In distribution
141-2013 Diameter: 2.0 Millimeter In distribution
141-2516 Length 16.0 mm In distribution
141-2010 Length 10.0 mm In distribution
141-2515 Length 15.0 mm In distribution
141-4026 Length 26.0 mm In distribution
141-2024 Length 24.0 mm In distribution
141-2529 Length 29.0 mm In distribution
141-2016 Diameter: 2.0 Millimeter In distribution
141-4024 Diameter: 4.0 Millimeter In distribution
141-4042 Diameter: 4.0 Millimeter In distribution
141-3026 Length 26.0 mm In distribution
141-3038 Length 38.0 mm In distribution
141-2026 Diameter: 2.0 Millimeter In distribution
141-4028 Length 28.0 mm In distribution
141-2025 Diameter: 2.0 Millimeter In distribution
241-6560 Diameter: 6.5 Millimeter In distribution
141-2021 Length 21.0 mm In distribution
141-4040 Diameter: 4.0 Millimeter In distribution
141-2023 Length 23.0 mm In distribution
141-3012 Diameter: 3.0 Millimeter In distribution
141-2028 Length 28.0 mm In distribution
141-3034 Length 34.0 mm In distribution
241-6550 Diameter: 6.5 Millimeter In distribution
141-3040 Diameter: 3.0 Millimeter In distribution
141-2517 Length 17.0 mm In distribution
141-4044 Diameter: 4.0 Millimeter In distribution
141-2012 Length 12.0 mm In distribution
141-2523 Length 23.0 mm In distribution
141-3014 Diameter: 3.0 Millimeter In distribution
241-6570 Length 70.0 mm In distribution
141-2522 Diameter: 2.5 Millimeter In distribution
141-2525 Diameter: 2.5 Millimeter In distribution
241-6585 Length 85.0 mm In distribution
141-3024 Length 24.0 mm In distribution
241-6545 Diameter: 6.5 Millimeter In distribution
141-4050 Length 50.0 mm In distribution
141-2518 Length 18.0 mm In distribution
141-4046 Length 46.0 mm In distribution
141-3028 Diameter: 3.0 Millimeter In distribution
141-3030 Length 30.0 mm In distribution
141-2527 Diameter: 2.5 Millimeter In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Screw, Fixation, Bone Synthes Gmbh 3,975
Aptus Medartis Inc. 3,623
Acumed Acumed LLC 3,187
Arthrex® Arthrex, Inc. 2,781
OsteoMed Osteomed 2,764
Screw, Fixation, Bone AAP Implantate AG 2,176
Screw, Fixation, Bone Zimmer, Inc. 1,993
Arix System Bone Screw Jeil Medical Corporation 1,875
Cannulated Screw System + Tyber Medical 1,814
Cannulated Compression Headless Screw Tyber Medical 1,621
Microware Bone Plates and Bone Screws Microware Precision Co., Ltd. 1,601
Anthem Globus Medical, Inc. 1,538

Showing 12 of 5,775. All products under Screw, Fixation, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K220319 2022-06-10
K213199 2022-01-11
K193366 2020-03-20
K183104 2019-06-10
K180500 2018-06-04
K173135 2017-11-27

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