Arthrex®
SuperMX NiTi Staple w/ Instrs, 18W x 15L
7manufacturers in China registered for this device type
80catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 5 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 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2017-12-22 |
| Record revised | 2024-02-08 (version 25) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-8719-2020 | In distribution | |
| AR-8713S | In distribution | |
| AR-8717-0907 | In distribution | |
| AR-8719MX-1515 | In distribution | |
| AR-8719MXDS-1815 | In distribution | |
| AR-8717-111512 | In distribution | |
| AR-8715 | In distribution | |
| AR-8715S | In distribution | |
| AR-1016NS | In distribution | |
| AR-8717DS-1110 | In distribution | |
| AR-8710 | In distribution | |
| AR-8718DS-131512 | In distribution | |
| AR-13123-08S | In distribution | |
| AR-8719DS-1815 | In distribution | |
| AR-8719DS-2020 | In distribution | |
| AR-8719DS-2015 | In distribution | |
| AR-13123-10 | In distribution | |
| AR-8719DS-2520 | In distribution | |
| AR-13123-16S | In distribution | |
| AR-13123-18 | In distribution | |
| AR-8718DS-1310 | In distribution | |
| AR-8708 | In distribution | |
| AR-8719-2015 | In distribution | |
| AR-1006NS | In distribution | |
| AR-13123-22S | In distribution | |
| AR-1011NS | In distribution | |
| AR-8719MX-2015 | In distribution | |
| AR-8719MXDS-2520 | In distribution | |
| AR-13123-08 | In distribution | |
| AR-8719MX-1815 | In distribution | |
| AR-8719-181815 | In distribution | |
| AR-8718-1512 | In distribution | |
| AR-8717-1110 | In distribution | |
| AR-8719DS-1818 | In distribution | |
| AR-8719-1818 | In distribution | |
| AR-8719MX-2020 | In distribution | |
| AR-8718DS-1512 | In distribution | |
| AR-8714 | In distribution | |
| AR-13123-14S | In distribution | |
| AR-8719-1815 | In distribution | |
| AR-8719MXDS-1515 | In distribution | |
| AR-8708-ST | In distribution | |
| AR-1006 | In distribution | |
| AR-1006MNS | In distribution | |
| AR-8719DS-181815 | In distribution | |
| AR-8719DS-1515 | In distribution | |
| AR-13123-12 | In distribution | |
| AR-13123-22 | In distribution | |
| AR-8719-1515 | In distribution | |
| AR-13123-12S | In distribution | |
| AR-8718-1310 | In distribution | |
| AR-1008 | In distribution | |
| AR-13123-16 | In distribution | |
| AR-8719MX-2520 | In distribution | |
| AR-8717DS-0907 | In distribution | |
| AR-8718CTDS-1310 | In distribution | |
| AR-8717DS-0910 | In distribution | |
| AR-13123-24S | In distribution | |
| AR-8719MXDS-2020 | In distribution | |
| AR-8719-2520 | In distribution | |
| AR-13123-20 | In distribution | |
| AR-8719MXDS-1818 | In distribution | |
| AR-13123-20S | In distribution | |
| AR-8710-S | In distribution | |
| AR-13123-24 | In distribution | |
| AR-13123-18S | In distribution | |
| AR-8719MX-1818 | In distribution | |
| AR-8708S | In distribution | |
| AR-1016 | In distribution | |
| AR-8717DS-111512 | In distribution | |
| AR-13123-10S | In distribution | |
| AR-8716S | In distribution | |
| AR-13123-14 | In distribution | |
| AR-8718-131512 | In distribution | |
| AR-1008NS | In distribution | |
| AR-8719MXDS-2015 | In distribution | |
| AR-8717-0910 | In distribution | |
| AR-1006M | In distribution | |
| AR-1011 | In distribution | |
| AR-8716 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DynaBridge | Fusion Orthopedics, LLC | 156 |
| Staple, Fixation, Bone | Smith & Nephew, Inc. | 59 |
| Compression Staple System | Tornier Inc. | 36 |
| UNI-Clip | Newdeal Sas | 35 |
| Z-Staple | Z-Medical Gmbh & Co. KG | 34 |
| Orbitum Staple System | CPM Medical Consultants, LLC. | 32 |
| OSStaple | Biomedical Enterprises, Inc. | 30 |
| Acumed | Acumed LLC | 30 |
| Stealthfix Intraosseous Fixation System | Medartis Inc. | 29 |
| Staple, Fixation, Bone | Stryker GmbH | 29 |
| Step Boss | Biomedical Enterprises, Inc. | 27 |
| Fuseforce | Wright Medical Technology, Inc. | 26 |
Showing 12 of 319. All products under Staple, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262451 | 2026-09-01 |
| K243742 | 2025-01-31 |
| K203180 | 2020-12-16 |
| K172052 | 2017-12-13 |
| K080111 | 2008-02-13 |
| K943492 | 1995-02-01 |
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.