Acufex
Acufex Access Advanced Positioning KIT
Who Else Makes It
Concentrated in Guangdong (6), Shanghai (5), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Shanghai Xodus Medical Company Limited | Shanghai | Shanghai | Specification developer | 25 |
| Zhongshan A&E Machinery Industry Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 25 |
| Shanghai Lejoy Co., Ltd. | Shanghai | Shanghai | Exporter | 21 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Drtv Asia Ltd | Panyu Guangzhou | Guangdong | Specification developer | 16 |
| Hebei Junlaole Medical Technology Co., Ltd. | Hengshui | Hebei | Manufacturer | 15 |
Showing 12 of 18. All 18 manufacturers in China registered for Component, Traction, Non-Invasive
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | KQZ |
| Device type | Component, Traction, Non-Invasive |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-11-16 |
| Record revised | 2025-02-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72205102 | In distribution | |
| 72205104 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 23 |
| Component, Traction, Non-Invasive | Smith & Nephew, Inc. | 13 |
| Component, Traction, Non-Invasive | MID Central Medical | 7 |
| BoneFoam | Bone Foam Inc. | 6 |
| Top Shelf Orthopedics | TOP Shelf Manufacturing, LLC | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 3 |
| Paradigm Revolution | ConMed Corporation | 2 |
| Bucks Boot XS | Bird & Cronin, LLC | 1 |
| Finger Trap SET (5), Pedi, Litegrip | Mizuho Orthopedic Systems, Inc. | 1 |
| Bucks Boot MD | Bird & Cronin, LLC | 1 |
| Deluxe Head Halter Univ Black | Bird & Cronin, LLC | 1 |
| BOW With Finger Trap SET | Mizuho Orthopedic Systems, Inc. | 1 |
Showing 12 of 46. All products under Component, Traction, Non-Invasive
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2021-12-14 | Class II | Nonconforming Material/Component | Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process | 271 units |
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.