UNI-Clip
The UNI-CLIP STAPLE is designed so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true…
The UNI-CLIP STAPLE is designed so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of sizes (11, 12, 13 or 15mm interaxis, and lengths vary from 13 to 20mm). The UNI-CLIP STAPLE is made from Stainless Steel and it is indicated for fixation of bone fractures or for bone reconstruction. It is delivered non sterile.
7manufacturers in China registered for this device type
35catalogue numbers in this listing
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 | Newdeal Sas, United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K061594 |
| Record published | 2017-10-09 |
| Record revised | 2023-05-22 (version 7) |
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 |
| Storage | Special storage condition: Store in dry place. |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 213316SND | 12.25mm interaxis x 14.5mm length x 16mm height | In distribution |
| 213114SND | 10.25mm interaxis x 12.5mm length x 14mm height | In distribution |
| 213316ND | 12.25mm interaxis x 14.5mm length x 16mm height | In distribution |
| 213314SND | 12.25mm interaxis x 14.5mm length x 14mm height | In distribution |
| 213216SND | 11.25mm interaxis x 13.5mm length x 16mm height | In distribution |
| 213314ND | 12.25mm interaxis x 14.5mm length x 14mm height | In distribution |
| 213317ND | 12.25mm interaxis x 14.5mm length x 17mm height | In distribution |
| 213214SND | 11.25mm interaxis x 13.5mm length x 14mm height | In distribution |
| 213512SND | 14.25mm interaxis x 16.5mm length x 12mm height | In distribution |
| 213113SND | 10.25mm interaxis x 12.5mm length x 13mm height | In distribution |
| 213117SND | 10.25mm interaxis x 12.5mm length x 17mm height | In distribution |
| 213117ND | 10.25mm interaxis x 12.5mm length x 17mm height | In distribution |
| 213116SND | 10.25mm interaxis x 12.5mm length x 16mm height | In distribution |
| 213213SND | 11.25mm interaxis x 13.5mm length x 13mm height | In distribution |
| 213215SND | 11.25mm interaxis x 13.5mm length x 15mm height | In distribution |
| 213820SND | 19.25mm interaxis x 21.5mm length x 20mm height | In distribution |
| 213114ND | 10.25mm interaxis x 12.5mm length x 14mm height | In distribution |
| 213116ND | 10.25mm interaxis x 12.5mm length x 16mm height | In distribution |
| 213820ND | 19.25mm interaxis x 21.5mm length x 20mm height | In distribution |
| 213217ND | 11.25mm interaxis x 13.5mm length x 17mm height | In distribution |
| 213115SND | 10.25mm interaxis x 12.5mm length x 15mm height | In distribution |
| 213315SND | 12.25mm interaxis x 14.5mm length x 15mm height | In distribution |
| 213313ND | 12.25mm interaxis x 14.5mm length x 13mm height | In distribution |
| 213214ND | 11.25mm interaxis x 13.5mm length x 14mm height | In distribution |
| 213217SND | 11.25mm interaxis x 13.5mm length x 17mm height | In distribution |
| 213113ND | 10.25mm interaxis x 12.5mm length x 13mm height | In distribution |
| 213313SND | 12.25mm interaxis x 14.5mm length x 13mm height | In distribution |
| 213216ND | 11.25mm interaxis x 13.5mm length x 16mm height | In distribution |
| 213215ND | 11.25mm interaxis x 13.5mm length x 15mm height | In distribution |
| 213512ND | 14.25mm interaxis x 16.5mm length x 12mm height | In distribution |
| 213317SND | 12.25mm interaxis x 14.5mm length x 17mm height | In distribution |
| 213315ND | 12.25mm interaxis x 14.5mm length x 15mm height | In distribution |
| 213115ND | 10.25mm interaxis x 12.5mm length x 15mm height | In distribution |
| 213213ND | 11.25mm interaxis x 13.5mm length x 13mm height | In distribution |
| LGUNICPINST | Withdrawn |
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 |
| 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
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.