Compression Staple System
Staple
7manufacturers in China registered for this device type
36catalogue 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 | Tornier Inc., United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-16 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 8 to 23 mm; width 8 to 25 mm |
| Distribution end date | 2022-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STP-003-191812 | Length 12 mm | Withdrawn |
| STP-003-252520 | Length 20 mm | Withdrawn |
| STP-003-252516 | Length 16 mm | Withdrawn |
| STP-003-202520 | Width 25 mm | Withdrawn |
| STP-003-161212 | Length 12 mm | Withdrawn |
| STP-003-191818 | Width 18 mm | Withdrawn |
| STP-003-252121 | Width 21 mm | Withdrawn |
| STP-003-161414 | Length 14 mm | Withdrawn |
| STP-003-202522 | Thickness 2 mm | Withdrawn |
| STP-003-160808 | Width 8 mm | Withdrawn |
| STP-003-252522 | Length 22 mm | Withdrawn |
| STP-003-191919 | Width 19 mm | Withdrawn |
| STP-003-191814 | Width 18 mm | Withdrawn |
| STP-003-191717 | Thickness 1.9 mm | Withdrawn |
| STP-003-191510 | Width 15 mm | Withdrawn |
| STP-003-161410 | Width 14 mm | Withdrawn |
| STP-003-191515 | Length 15 mm | Withdrawn |
| STP-003-161010 | Thickness 1.6 mm | Withdrawn |
| STP-003-202016 | Thickness 2 mm | Withdrawn |
| STP-003-252020 | Length 20 mm | Withdrawn |
| STP-003-160909 | Width 9 mm | Withdrawn |
| STP-003-161111 | Thickness 1.6 mm | Withdrawn |
| STP-003-252016 | Length 16 mm | Withdrawn |
| STP-003-191520 | Length 20 mm | Withdrawn |
| STP-003-191512 | Thickness 1.9 mm | Withdrawn |
| STP-003-202020 | Width 20 mm | Withdrawn |
| STP-003-202323 | Thickness 2 mm | Withdrawn |
| STP-003-202121 | Thickness 2 mm | Withdrawn |
| STP-003-161313 | Width 13 mm | Withdrawn |
| STP-003-191616 | Width 16 mm | Withdrawn |
| STP-003-202424 | Length 23 mm | Withdrawn |
| STP-003-202220 | Width 22 mm | Withdrawn |
| STP-003-161210 | Length 12 mm | Withdrawn |
| STP-003-252222 | Length 22 mm | Withdrawn |
| STP-003-202222 | Width 22 mm | Withdrawn |
| STP-003-252220 | Thickness 2.5 mm | 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 |
| 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
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.