Brasseler USA
KM169-29-53S 5/32 X 9" DBL Troc
9manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Record published | 2022-12-01 |
| Record revised | 2025-02-06 (version 4) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5027847M1 | In distribution | |
| 5014437M0 | In distribution | |
| 5014431M0 | In distribution | |
| 5014447M0 | In distribution | |
| 5014450M0 | In distribution | |
| 5014444M0 | In distribution | |
| 5014453M0 | In distribution | |
| 5029502M0 | In distribution | |
| 5014449M0 | In distribution | |
| 5014438M0 | In distribution | |
| 5014439M0 | In distribution | |
| 5014445M0 | In distribution | |
| 5014432M0 | In distribution | |
| 5014440M0 | In distribution | |
| 5029501M0 | In distribution | |
| 5014429M0 | In distribution | |
| 5014430M0 | In distribution | |
| 5014452M0 | In distribution | |
| 5014451M0 | In distribution | |
| 5014442M0 | In distribution | |
| 5014427M0 | In distribution | |
| 5014446M0 | In distribution | |
| 5014454M0 | In distribution | |
| 5026882M0 | In distribution | |
| 5014443M0 | In distribution | |
| 5029503M0 | In distribution | |
| 5014441M0 | In distribution | |
| 5027848M0 | In distribution | |
| 5014433M0 | In distribution | |
| 5014436M0 | In distribution | |
| 5014428M0 | In distribution | |
| 5014434M0 | In distribution | |
| 5026883M0 | In distribution | |
| 5014435M0 | In distribution | |
| 5014448M0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Apex | Stryker GmbH | 176 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
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.