Breckenridge Acdf System

Trial Acdf 1MM Stop 5DEG 13X16X 11-12MM

Registry build 21.09.26
21manufacturers in China registered for this device type
72catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWT
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
Canwell Medical Co., Ltd. Jinhua Zhejiang 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
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Guangzhou Clean Medical Products Manufacturing Corp Guangzhou Guangdong Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 21. All 21 manufacturers in China registered for Template

Record

Regulatory record for Breckenridge Acdf System
Listed by Highridge Medical, LLC, United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2025-11-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization

Catalogue Numbers

Catalogue numbers for Breckenridge Acdf System
Catalogue number Size Status
8842-1711 In distribution
8842-1707 In distribution
8842-1607 In distribution
8842-2727 In distribution
8842-1411 In distribution
8842-1605 In distribution
8842-1307 In distribution
8842-2621 In distribution
8842-0411 In distribution
8842-2725 In distribution
8842-1405 In distribution
8842-2707 In distribution
8842-2625 In distribution
8842-1305 In distribution
8842-1207 In distribution
8842-1205 In distribution
8842-1807 In distribution
8842-1109 In distribution
8842-1407 In distribution
8842-2709 In distribution
8842-0407 In distribution
8842-2729 In distribution
8842-0311 In distribution
8842-1311 In distribution
8842-2609 In distribution
8842-2701 In distribution
8842-1609 In distribution
8842-1409 In distribution
8842-0209 In distribution
8842-0205 In distribution
8842-2619 In distribution
8842-2721 In distribution
8842-2627 In distribution
8842-0405 In distribution
8842-0211 In distribution
8842-0307 In distribution
8842-1211 In distribution
8842-1509 In distribution
8842-0107 In distribution
8842-0105 In distribution
8842-1111 In distribution
8842-1811 In distribution
8842-0305 In distribution
8842-2607 In distribution
8842-1105 In distribution
8842-2715 In distribution
8842-1505 In distribution
8842-1709 In distribution
8842-0409 In distribution
8842-1611 In distribution
8842-2629 In distribution
8842-0309 In distribution
8842-0109 In distribution
8842-2719 In distribution
8842-2705 In distribution
8842-1209 In distribution
8842-2611 In distribution
8842-1507 In distribution
8842-2605 In distribution
8842-1705 In distribution
8842-0111 In distribution
8842-1805 In distribution
8842-1511 In distribution
8842-2617 In distribution
8842-1309 In distribution
8842-2615 In distribution
8842-0207 In distribution
8842-2717 In distribution
8842-2601 In distribution
8842-2711 In distribution
8842-1107 In distribution
8842-1809 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Attune Depuy (Ireland) 1,385
Template Exactech, Inc. 1,277
4WEB Medical 4WEB Inc. 991
Evolution® Microport Orthopedics Inc. 966
Template Zimmer, Inc. 792
Advance® Microport Orthopedics Inc. 644
Apex Knee System Omni Life Science, Inc. 635
Profemur® Microport Orthopedics Inc. 591
Link Instruments – Trial implants and size gauges Waldemar Link GmbH & Co. KG 549
Template Synthes Gmbh 516
Optetrak Logic Exactech, Inc. 512
Template Depuy Spine, Inc. 451

Showing 12 of 2,940. All products under Template

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