Stealthfix Intraosseous Fixation System
StealthFix Ti Implant 4.5mm Post x 20mm Span x 32mm Long
7manufacturers in China registered for this device type
29catalogue numbers in this listing
2510(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 | Medartis 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 |
| 510(k) | K220181 |
| Record published | 2022-08-04 |
| Record revised | 2023-09-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SF452032 | In distribution | |
| SF451516 | In distribution | |
| SF451514 | In distribution | |
| SF3315 | In distribution | |
| SF452028 | In distribution | |
| SF451526 | In distribution | |
| SF3420 | In distribution | |
| SF452014 | In distribution | |
| SF451518 | In distribution | |
| SF451528 | In distribution | |
| SF3316 | In distribution | |
| SF452016 | In distribution | |
| SF451520 | In distribution | |
| SF452026 | In distribution | |
| SF452022 | In distribution | |
| SF451530 | In distribution | |
| SF451522 | In distribution | |
| SF452020 | In distribution | |
| SF451524 | In distribution | |
| SF351518 | In distribution | |
| SF452030 | In distribution | |
| SF3415 | In distribution | |
| SF351520 | In distribution | |
| SF452024 | In distribution | |
| SF451532 | In distribution | |
| SF351516 | In distribution | |
| SF452018 | In distribution | |
| SF351514 | In distribution | |
| SF3416 | 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 |
| OSStaple | Biomedical Enterprises, Inc. | 30 |
| Acumed | Acumed LLC | 30 |
| 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 |
|---|---|
| K232324 | 2023-08-30 |
| K191636 | 2019-08-16 |
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.