DynaBridge
Superelastic Nitinol 3 Prong Right Offset Implant Style A 20mm x 17mm x 17mm (Sterile)
7manufacturers in China registered for this device type
156catalogue 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 | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | JDR |
| Device type | Staple, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K181815 |
| Record published | 2025-02-10 |
| Record revised | 2025-07-16 (version 3) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DB-4P-3016-SC | In distribution | |
| CD-DB-4015-A | In distribution | |
| CD-DB-2717-SA | In distribution | |
| CD-DB-1006-SB | In distribution | |
| TN-DB-1515 | In distribution | |
| CD-DB-CI12 | In distribution | |
| DB-4P-2620-SC | In distribution | |
| DB-CS-0006-SB1 | In distribution | |
| TN-DB-2020 | In distribution | |
| DB-15-1212-A | In distribution | |
| DB-18-1815-SB1 | In distribution | |
| TN-DB-3050 | In distribution | |
| CD-DB-4025-B | In distribution | |
| CD-DB-1111-SA | In distribution | |
| CD-DB-CI04-S | In distribution | |
| DB-CB-0008-B | In distribution | |
| DB-09-0808-SA1 | In distribution | |
| CD-DB-CI12-S | In distribution | |
| CD-DB-CI04 | In distribution | |
| DB-CS-00010-B | In distribution | |
| DB-CS-0006-SB | In distribution | |
| TN-DB-1313 | In distribution | |
| DB-11-1010-SA | In distribution | |
| DB-CS-0004-SB | In distribution | |
| TN-DB-1111 | In distribution | |
| DB-3P-2717-SA | In distribution | |
| DB-18-1815-SB | In distribution | |
| DB-15-1212-SB1 | In distribution | |
| DB-CS-0008-SB | In distribution | |
| CD-DB-6010-SA | In distribution | |
| DB-CS-0014-SB1 | In distribution | |
| CD-DB-1515-SB | In distribution | |
| DB-3P-2210-SA | In distribution | |
| DB-CS-0012-B | In distribution | |
| CD-DB-0909-SA | In distribution | |
| CD-DB-2028 | In distribution | |
| CD-DB-4015-B | In distribution | |
| TN-DB-1818 | In distribution | |
| CD-DB-3TI0 | In distribution | |
| CD-DB-3OI0 | In distribution | |
| DB-CS-0012-SB | In distribution | |
| TN-DB-2525 | In distribution | |
| DB-3P-2217-SA1 | In distribution | |
| DB-18-1515-SB1 | In distribution | |
| CD-DB-6020-SB | In distribution | |
| TN-DB-3050 | In distribution | |
| DB-4P-3016-SC1 | In distribution | |
| DB-15-1212-SB | In distribution | |
| DB-15-1212-B | In distribution | |
| CD-DB-3016-SC | In distribution | |
| CD-DB-CI06-S | In distribution | |
| DB-11-1010-A | In distribution | |
| DB-20-1515-SB1 | In distribution | |
| CD-DB-2021 | In distribution | |
| DB-CS-00010-SB | In distribution | |
| CD-DB-2017-SA | In distribution | |
| CD-DB-2030-S | In distribution | |
| CD-DB-6020-SA | In distribution | |
| CD-DB-35I0-S | In distribution | |
| CD-DB-6030-S | In distribution | |
| CD-DB-3020 | In distribution | |
| CD-DB-CI08 | In distribution | |
| DB-18-1515-B | In distribution | |
| DB-3P-2217-SA | In distribution | |
| DB-09-0808-SA | In distribution | |
| CD-DB-CI08-S | In distribution | |
| TN-DB-1515 | In distribution | |
| DB-11-1010-SA1 | In distribution | |
| DB-3P-2717-SA1 | In distribution | |
| TN-DB-2050 | In distribution | |
| DB-20-1515-B | In distribution | |
| CD-DB-1004-SB | In distribution | |
| CD-DB-6020-B | In distribution | |
| CD-DB-1008-SB | In distribution | |
| DB-15-1515-B | In distribution | |
| DB-4P-2620-SC1 | In distribution | |
| CD-DB-4011-A | In distribution | |
| DB-13-1010-SA1 | In distribution | |
| CD-DB-4013-A | In distribution | |
| DB-20-1515-SB | In distribution | |
| TN-DB-1313 | In distribution | |
| DB-CS-0006-B | In distribution | |
| DB-25-2020-B | In distribution | |
| DB-3P-2017-A | In distribution | |
| DB-4P-3016-SB | In distribution | |
| DB-CS-0014-SB | In distribution | |
| TN-DB-1111 | In distribution | |
| CD-DB-1014-SB | In distribution | |
| CD-DB-1515-SA | In distribution | |
| CD-DB-3TI0-S | In distribution | |
| DB-18-1818-SB | In distribution | |
| DB-25-2020-SB1 | In distribution | |
| CD-DB-CI14 | In distribution | |
| TN-DB-0909 | In distribution | |
| DB-4P-2620-SB | In distribution | |
| CD-DB-CI06 | In distribution | |
| DB-18-1815-B | In distribution | |
| DB-CS-0004-B | In distribution | |
| DB-15-1212-SA1 | In distribution | |
| DB-20-2020-SB | In distribution | |
| DB-CS-0014-B | In distribution | |
| DB-CS-0008-SB1 | In distribution | |
| CD-DB-1012-SB | In distribution | |
| DB-13-1010-A | In distribution | |
| CD-DB-2020-SB | In distribution | |
| DB-15-1212-SA | In distribution | |
| CD-DB-6010-A | In distribution | |
| DB-3P-2210-A | In distribution | |
| DB-3P-2017-SA1 | In distribution | |
| CD-DB-2525-SB | In distribution | |
| CD-DB-CI10-S | In distribution | |
| CD-DB-4020-B | In distribution | |
| CD-DB-2030 | In distribution | |
| CD-DB-2620-SC | In distribution | |
| CD-DB-1010-SB | In distribution | |
| TN-DB-2020 | In distribution | |
| CD-DB-4SI0 | In distribution | |
| DB-09-0808-A | In distribution | |
| DB-13-1010-SA | In distribution | |
| CD-DB-CI10 | In distribution | |
| DB-4P-2620-B | In distribution | |
| DB-25-2020-SB | In distribution | |
| TN-DB-1818 | In distribution | |
| DB-15-1515-SB1 | In distribution | |
| CD-DB-3010 | In distribution | |
| CD-DB-2217-SA | In distribution | |
| CD-DB-1815-SB | In distribution | |
| CD-DB-4TI0-S | In distribution | |
| TN-DB-2050 | In distribution | |
| DB-18-1515-SB | In distribution | |
| CD-DB-4SI0-S | In distribution | |
| DB-CS-0010-SB | In distribution | |
| CD-DB-4009-A | In distribution | |
| DB-18-1818-SB1 | In distribution | |
| DB-4P-3016-B | In distribution | |
| DB-CS-0004-SB1 | In distribution | |
| CD-DB-1818-SB | In distribution | |
| TN-DB-2525 | In distribution | |
| CD-DB-3OI0-S | In distribution | |
| DB-3P-2017-SA | In distribution | |
| CD-DB-2028-S | In distribution | |
| DB-CS-0010-SB1 | In distribution | |
| CD-DB-2015 | In distribution | |
| TN-DB-0909 | In distribution | |
| CD-DB-4018-B | In distribution | |
| CD-DB-CI14-S | In distribution | |
| DB-CS-0012-SB1 | In distribution | |
| DB-18-1818-B | In distribution | |
| DB-20-2020-SB1 | In distribution | |
| CD-DB-4TI0 | In distribution | |
| CD-DB-1313-SA | In distribution | |
| DB-20-2020-B | In distribution | |
| DB-15-1515-SB | In distribution | |
| CD-DB-6020-A | In distribution | |
| CD-DB-2015-S | In distribution | |
| CD-DB-2021-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Fuseforce | Wright Medical Technology, Inc. | 26 |
Showing 12 of 319. All products under Staple, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181815 | 2018-10-15 |
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.