Fuseforce
26 catalogue numbers from FFNS0808, listed by Wright Medical Technology, Inc., United States, under Staple, Fixation, Bone. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
26catalogue numbers in this listing
1510(k) clearance
1recall
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 | Wright Medical Technology, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K124045 |
| Record published | 2015-10-02 |
| Record revised | 2022-05-10 (version 5) |
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, manufacturing date |
| Sizes | Length 8 to 22 mm; width 8 to 25 mm |
| Distribution end date | 2016-03-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FFNS0808 | Length 8 mm | In distribution |
| 10135 | Width 10 mm | In distribution |
| FFNS1010 | Length 10 mm | In distribution |
| FFS-1212 | Length 12 mm | In distribution |
| FFS-1012 | Length 12 mm | In distribution |
| 10138 | Width 18 mm | In distribution |
| FFNS1012 | Width 10 mm | In distribution |
| FFS-0808 | Length 8 mm | In distribution |
| FFNS1212 | Width 12 mm | In distribution |
| FFNS2522 | Width 25 mm | In distribution |
| FFS-1816 | Length 16 mm | In distribution |
| FFNS2020 | Width 20 mm | In distribution |
| FFS-1515 | Length 15 mm | In distribution |
| FFS-1010 | Length 10 mm | In distribution |
| FFS-101513 | Length 15 mm | In distribution |
| FFS-2522 | Length 22 mm | In distribution |
| FFNS101513 | Length 13 mm | In distribution |
| 10140 | Length 20 mm | In distribution |
| 10137 | Width 15 mm | In distribution |
| FFNS1515 | Width 15 mm | In distribution |
| T10 SS026 | Size: 1mm-10mm | In distribution |
| 10134 | Width 8 mm | In distribution |
| FFNS1816 | Width 18 mm | In distribution |
| T10 SS090 | Size: 1mm-10mm | In distribution |
| FFS-2020 | Length 20 mm | In distribution |
| 10386 | Size: 10 x 15 x 13 | 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 |
| 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 |
|---|---|
| K203832 | 2021-05-07 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-03-10 | Class II | Device Design | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. | 176 packs | 2026-04-01 |
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.