Instrument, Compression
Short Compression Device FOR TI Cannulated Tibial Nails-EX
8manufacturers in China registered for this device type
78catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (3), Guangdong (1). 2 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 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Qingdao Taniking Garment Co., Ltd. | Qingdao | Shandong | Manufacturer | 2 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HWN |
| Device type | Instrument, Compression |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2024-09-11 (version 7) |
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 | Per pack | Status |
|---|---|---|---|
| 03.118.050S | In distribution | ||
| 03.043.023 | In distribution | ||
| 03.010.136 | In distribution | ||
| SD321.121 | In distribution | ||
| 03.118.060S | In distribution | ||
| 03.118.035S | In distribution | ||
| 03.111.024 | In distribution | ||
| 03.118.008 | In distribution | ||
| 03.211.430 | In distribution | ||
| 03.118.010S | In distribution | ||
| SD03.212.220 | 5 | In distribution | |
| 03.211.410 | In distribution | ||
| 03.118.030 | In distribution | ||
| SD03.212.120 | 5 | In distribution | |
| SD03.212.110 | 5 | In distribution | |
| SD03.212.210 | 5 | In distribution | |
| 03.111.022 | In distribution | ||
| 03.111.021 | In distribution | ||
| 03.118.010 | In distribution | ||
| 03.118.055S | In distribution | ||
| SD321.122 | In distribution | ||
| SD03.212.320 | 5 | In distribution | |
| 03.118.040 | In distribution | ||
| 399.13 | In distribution | ||
| 03.118.040S | In distribution | ||
| 03.118.035 | In distribution | ||
| 03.118.060 | In distribution | ||
| 03.118.005 | In distribution | ||
| 03.118.020 | In distribution | ||
| 388.488 | In distribution | ||
| SD03.211.416 | In distribution | ||
| 03.111.023 | In distribution | ||
| 03.211.440 | In distribution | ||
| SD03.211.415 | In distribution | ||
| 03.118.045S | In distribution | ||
| 03.211.400 | In distribution | ||
| 03.118.006 | In distribution | ||
| 03.010.015 | In distribution | ||
| 03.010.137 | In distribution | ||
| SD03.212.030 | 5 | In distribution | |
| SD03.212.230 | 5 | In distribution | |
| 03.043.020 | In distribution | ||
| 03.118.020S | In distribution | ||
| 03.118.004 | In distribution | ||
| SD03.212.330 | 5 | In distribution | |
| 388.038 | In distribution | ||
| 321.12 | In distribution | ||
| 03.211.425 | In distribution | ||
| 03.118.045 | In distribution | ||
| 03.043.026 | In distribution | ||
| SD03.212.130 | 5 | In distribution | |
| SD03.212.310 | 5 | In distribution | |
| SD393.760 | In distribution | ||
| 03.118.015S | In distribution | ||
| 03.118.015 | In distribution | ||
| SD357.029 | In distribution | ||
| 321.121 | In distribution | ||
| 388.489 | In distribution | ||
| SD03.212.215 | 5 | In distribution | |
| SD03.632.205 | In distribution | ||
| 03.111.041 | In distribution | ||
| 03.211.415 | In distribution | ||
| SD03.212.020 | 5 | In distribution | |
| SD03.212.115 | 5 | In distribution | |
| SD357.013 | In distribution | ||
| 03.118.025 | In distribution | ||
| 357.370 | In distribution | ||
| 03.118.050 | In distribution | ||
| SD03.212.015 | 5 | In distribution | |
| SD03.212.315 | 5 | In distribution | |
| 03.118.025S | In distribution | ||
| 03.211.420 | In distribution | ||
| 03.211.435 | In distribution | ||
| 03.010.443 | In distribution | ||
| 03.226.006 | In distribution | ||
| 03.118.055 | In distribution | ||
| 03.118.030S | In distribution | ||
| SD03.212.010 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 42 |
| Invictus | Alphatec Spine, Inc. | 37 |
| Axle Interspinous Fusion System | Xtant Medical Holdings, Inc. | 35 |
| TrabecuLink Femoral and Tibial Cone – Instruments | Waldemar Link GmbH & Co. KG | 32 |
| Made-To-Order | Tornier Inc. | 28 |
| Instrument, Compression | Medtronic Sofamor Danek, Inc. | 20 |
| Tornier Flex | Tornier Inc. | 16 |
| General Instruments | Alphatec Spine, Inc. | 16 |
| Alpine XC Adjustable Fusion System | Highridge Medical, LLC | 14 |
| Coral | Seaspine Orthopedics Corporation | 12 |
| CosmoLock Pedicle Screw System | Kalitec Direct, LLC | 9 |
| Apelo® / Apelo® MIS | Atlas Spine Inc. | 9 |
Showing 12 of 196. All products under Instrument, Compression
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.