Uhead
Ulnar Broach Assembly; Size 1
12manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HTQ |
| Device type | Broach |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-04-14 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17-1106 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 132 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 119 |
| DJO Surgical | DJO, LLC | 89 |
| iNSitu™ Hip System | Nextstep Arthropedix | 84 |
| OrthoMedFlex | Orthomedflex LLC | 63 |
| Anthology | Smith & Nephew, Inc. | 56 |
| LinkBio Instrument | Link BIO Corp | 53 |
| Profemur® | Microport Orthopedics Inc. | 47 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 40 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 39 |
| Polar | Smith & Nephew, Inc. | 36 |
| Integra® | Ascension Orthopedics, Inc. | 36 |
Showing 12 of 216. All products under Broach
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.