Instrument
Bone File Triathlon Instruments
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (4), Shandong (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HTP |
| Device type | File |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-11-13 |
| Record revised | 2023-06-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6541-4-700 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acetabular bone rasp | Xinhua Healthcare Industry Co., Limited | 36 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 16 |
| Novo Surgical | Novo Surgical, Inc. | 15 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 8 |
| TaperSet Hip System | Shalby Advanced Technologies, Inc. | 6 |
| Rasp Up Bend 20° | T.A.G Medical Products Agricultural Cooperative Association | 6 |
| Rasp Down Bend 20° | T.A.G Medical Products Agricultural Cooperative Association | 6 |
| gSource | Gsource, LLC. | 5 |
| Aesculap | Aesculap AG | 5 |
| Kmedic | Teleflex Medical LLC | 4 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 4 |
| Ambler Surgical | Ambler Surgical, LLC | 4 |
Showing 12 of 38. All products under File
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.