DynafitSystem
Superelastic staple 10 x 10 x 10mm sterile
7manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
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 | Neosteo, France |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K192447 |
| Record published | 2020-12-15 |
| Record revised | 2021-11-23 (version 2) |
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 |
| Storage | Storage environment temperature 15 to 25 °C; Special storage condition: Device must be stored in a place protected from light and humidity |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A5101010 | Inter-Leg Distance 10mm, Leg Lengths 10x10mm | In distribution |
| A5252222 | Inter-Leg Distance 25mm, Leg Lengths 22x22mm | In distribution |
| A5101315 | Inter-Leg Distance 10mm, Leg Lengths 13x15mm | In distribution |
| A5151515 | Inter-Leg Distance 15mm, Leg Lengths 15x15mm | In distribution |
| A5201616 | Inter-Leg Distance 20mm, Leg Lengths 16x16mm | In distribution |
| A5101719 | Inter-Leg Distance 10mm, Leg Lengths 17x19mm | In distribution |
| A5121315 | Inter-Leg Distance 12mm, Leg Lengths 13x15mm | In distribution |
| A5181212 | Inter-Leg Distance 18mm, Leg Lengths 12x12mm | In distribution |
| A5101517 | Inter-Leg Distance 10mm, Leg Lengths 15x17mm | In distribution |
| A5121010 | Inter-Leg Distance 12mm, Leg Lengths 10x10mm | In distribution |
| A5080808 | Inter-Leg Distance 08mm, Legs Lengths 08×08 mm | In distribution |
| A5121719 | Inter-Leg Distance 12mm, Leg Lengths 17x19mm | In distribution |
| A5121517 | Inter-Leg Distance 12mm, Leg Lengths 15x17mm | In distribution |
| A5202020 | Inter-Leg Distance 20mm, Leg Lengths 20x20mm | In distribution |
| A5151212 | Inter-Leg Distance 15mm, Leg Lengths 12x12mm | In distribution |
| A5181515 | Inter-Leg Distance 18mm, Leg Lengths 15x15mm | In distribution |
| A5181517 | Inter-Leg Distance 18mm, Leg Lengths 15x17mm | In distribution |
| A5181719 | Inter-Leg Distance 18mm, Leg Lengths 17x19mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DynaBridge | Fusion Orthopedics, LLC | 156 |
| Arthrex® | Arthrex, Inc. | 80 |
| 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 |
Showing 12 of 319. All products under Staple, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192447 | 2020-02-28 |
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.