Arthrex®
ANKLE DISTRACTOR, DM DI is different from Primary DI; DM DI = 00615521004668
44manufacturers in China registered for this device type
48catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (13), Fujian (10), Zhejiang (6). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Hengshui Tianjian Medical Supplies Co., Ltd. | Shenzhou | Hebei | Contract manufacturer | 14 |
| Jianxing Shoe Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 11 |
| Shanghai Huifeng Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Worldcross Industries Co., Ltd. | Dong Yang | Zhejiang | Contract manufacturer | 3 |
| Fullmark (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 1 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 44. All 44 manufacturers in China registered for Apparatus, Traction, Non-Powered
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | HST |
| Device type | Apparatus, Traction, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5850 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-07-22 |
| Record revised | 2026-02-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 6, box of 5 |
| Distribution end date | 2026-02-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-6529-01 | In distribution | |
| AR-1609 | In distribution | |
| AR-6529-02 | In distribution | |
| AR-8950JD | In distribution | |
| AR-1604 | In distribution | |
| AR-1602D | In distribution | |
| AR-16000602 | In distribution | |
| AR-1608 | In distribution | |
| AR-1525P | In distribution | |
| AR-1614 | In distribution | |
| AR-1607 | In distribution | |
| AR-6529-04 | In distribution | |
| AR-1713S | In distribution | |
| AR-6529-25 | In distribution | |
| AR-1600SS | In distribution | |
| AR-6529-07 | In distribution | |
| AR-6529-23 | In distribution | |
| AR-1610 | In distribution | |
| AR-1600A-02 | In distribution | |
| AR-6529-16 | In distribution | |
| AR-1651 | In distribution | |
| AR-16001500 | In distribution | |
| AR-6529-08 | In distribution | |
| AR-6529-03 | In distribution | |
| AR-8950JDC | In distribution | |
| AR-8970JD | In distribution | |
| AR-1710 | In distribution | |
| AR-16110200 | In distribution | |
| AR-6529-14L | In distribution | |
| AR-16001607 | In distribution | |
| AR-6529-24 | In distribution | |
| AR-1600M | In distribution | |
| AR-16001400 | In distribution | |
| AR-6529-06 | In distribution | |
| AR-16110407 | In distribution | |
| AR-16001200 | In distribution | |
| AR-16000510 | In distribution | |
| AR-1712 | In distribution | |
| AR-6529-21 | In distribution | |
| AR-1611S | In distribution | |
| AR-6529-22 | In distribution | |
| AR-1652 | In distribution | |
| AR-6529-09 | In distribution | |
| AR-16110300 | In distribution | |
| AR-6529-05 | In distribution | |
| AR-1600A-01 | In distribution | |
| AR-16001408 | In distribution | |
| AR-1713-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apparatus, Traction, Non-Powered | Zimmer Orthopaedic Surgical Products | 120 |
| Apparatus, Traction, Non-Powered | Synthes Gmbh | 29 |
| Acumed | Acumed LLC | 16 |
| Pivot Guardian | Stryker GmbH | 15 |
| Active Heel Traction Boot | Smith & Nephew, Inc. | 10 |
| Paradigm Revolution | ConMed Corporation | 10 |
| Morrison Medical | Morrison Corporation | 8 |
| Apparatus, Traction, Non-Powered | Steris Corporation | 7 |
| Allen | Hill-ROM, Inc. | 6 |
| Arthrex | Allen Medical Systems, Inc. | 5 |
| Span-America | Span-America Medical Systems, Inc. | 5 |
| Kmedic | Teleflex Medical LLC | 3 |
Showing 12 of 71. All products under Apparatus, Traction, Non-Powered
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.