OSStaple
OSStaple 18 x 15 x 15 mm implant 2mm diameter legs
7manufacturers in China registered for this device type
30catalogue numbers in this listing
4510(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 | Biomedical Enterprises, Inc., United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Record published | 2015-10-24 |
| Record revised | 2021-11-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: May be stored at room temperature |
| Sizes | Length 5 to 30 mm; width 7 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP-1506 | Length 06 mm | In distribution |
| OS-1518W1.5 | Width 15 mm | In distribution |
| OS-1518W2 | Width 15 mm | In distribution |
| OS-1830W2X3 | Length 30 mm | In distribution |
| OS-1825W2 | Length 25 mm | In distribution |
| OS-2020W2X3 | Length 20 mm | In distribution |
| OS-1310W1.5 | Length 10 mm | In distribution |
| OS-3030W2x3 | Length 30 mm | In distribution |
| OS-1515W1.5 | Length 15 mm | In distribution |
| OS-0907W1.2 | Width 09 mm | In distribution |
| OS-0907W1.5 | Width 09 mm | In distribution |
| OS-0705W1.5 | Length 05 mm | In distribution |
| OS-1825W2 | Width 18 mm | In distribution |
| OS-111917W1.5 | Length 17 mm | In distribution |
| OS-1512W1.5 | Width 15 mm | In distribution |
| OS-1515W2 | Length 15 mm | In distribution |
| OS-181815W2 | Length 18 mm | In distribution |
| OS-1512W2 | Width 15 mm | In distribution |
| OS-111513W1.5 | Length 13 mm | In distribution |
| OS-1108W1.5 | Length 08 mm | In distribution |
| OS-1110W1.5 | Width 11 mm | In distribution |
| OS-111715W1.5 | Width 11 mm | In distribution |
| OS-0705W1.2 | Length 05 mm | In distribution |
| OP-1508 | Width 15 mm | In distribution |
| OS-1815W2 | Length 15 mm | In distribution |
| OS-2020W2 | Width 20 mm | In distribution |
| OS-2020W2X3 | Width 20 mm | In distribution |
| OS-2522W2x3 | Width 25 mm | In distribution |
| OS-2015W1.5 | Length 15 mm | In distribution |
| OP-1510 | Length 10 mm | 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 |
| 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 |
|---|---|
| K150125 | 2015-05-11 |
| K142292 | 2014-11-17 |
| K133270 | 2014-04-17 |
| K124022 | 2013-05-14 |
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.