Gauge, Depth
Insertn Handle F/3.5MM LOW BND Medial Distal Tibia Plate/LEF
14manufacturers in China registered for this device type
119catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Jiangsu (3), Zhejiang (2). 7 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 14. All 14 manufacturers in China registered for Gauge, Depth
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HTJ |
| Device type | Gauge, Depth |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4300 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2023-02-03 (version 6) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 351.719 | In distribution | |
| 03.120.049 | In distribution | |
| SD351.726 | In distribution | |
| 03.207.004 | In distribution | |
| 319.09 | In distribution | |
| 319.703 | In distribution | |
| 03.010.021 | In distribution | |
| SD319.073 | In distribution | |
| 03.010.429 | In distribution | |
| 03.122.052 | In distribution | |
| 03.240.001 | In distribution | |
| 319.15 | In distribution | |
| 03.424.060 | In distribution | |
| 03.113.026 | In distribution | |
| 323.025 | In distribution | |
| 03.037.036 | In distribution | |
| 357.792 | In distribution | |
| 319.091 | In distribution | |
| 319.006 | In distribution | |
| SD319.010 | In distribution | |
| SD03.010.072 | In distribution | |
| SD03.010.019 | In distribution | |
| SD03.333.501 | In distribution | |
| 319.51 | In distribution | |
| 03.113.014 | In distribution | |
| 03.161.028 | In distribution | |
| 357.385 | In distribution | |
| SD319.009 | In distribution | |
| 319.009 | In distribution | |
| 319.17 | In distribution | |
| 333.37 | In distribution | |
| SD03.133.006 | In distribution | |
| 319.52 | In distribution | |
| 03.010.494 | In distribution | |
| 03.168.017 | In distribution | |
| 03.535.110 | In distribution | |
| 03.010.020 | In distribution | |
| 03.501.001 | In distribution | |
| SD351.725 | In distribution | |
| 03.113.025 | In distribution | |
| 03.010.023 | In distribution | |
| 03.045.035 | In distribution | |
| SD319.150 | In distribution | |
| SD351.717 | In distribution | |
| SD319.002 | In distribution | |
| 393.78 | In distribution | |
| 03.010.090 | In distribution | |
| 319.70 | In distribution | |
| 324.208 | In distribution | |
| SD319.070 | In distribution | |
| 319.06 | In distribution | |
| 03.226.030 | In distribution | |
| SD319.072 | In distribution | |
| 03.010.428 | In distribution | |
| 03.010.022 | In distribution | |
| 03.427.060 | In distribution | |
| 03.108.037 | In distribution | |
| SD319.001 | In distribution | |
| 03.130.215 | In distribution | |
| 319.21 | In distribution | |
| SD319.704 | In distribution | |
| 323.060 | In distribution | |
| 03.305.005 | In distribution | |
| SD03.010.073 | In distribution | |
| 03.168.003 | In distribution | |
| 03.133.082 | In distribution | |
| 319.10 | In distribution | |
| 03.420.050 | In distribution | |
| 03.010.493 | In distribution | |
| 03.164.028 | In distribution | |
| 319.011 | In distribution | |
| 03.227.030 | In distribution | |
| SD03.010.107 | In distribution | |
| 03.110.006 | In distribution | |
| 03.133.081 | In distribution | |
| 319.11 | In distribution | |
| 03.010.085 | In distribution | |
| SD351.721 | In distribution | |
| 03.113.022 | In distribution | |
| 03.113.021 | In distribution | |
| 03.010.072 | In distribution | |
| 351.717 | In distribution | |
| 319.53 | In distribution | |
| 323.021 | In distribution | |
| SD03.019.017 | In distribution | |
| SD03.333.500 | In distribution | |
| 319.701 | In distribution | |
| SD351.719 | In distribution | |
| SD03.333.502 | In distribution | |
| 03.108.003 | In distribution | |
| 387.550 | In distribution | |
| 03.025.052 | In distribution | |
| 03.110.021 | In distribution | |
| 357.391 | In distribution | |
| 319.004 | In distribution | |
| 357.402 | In distribution | |
| SD319.007 | In distribution | |
| SD03.010.106 | In distribution | |
| 03.130.250 | In distribution | |
| 03.010.106 | In distribution | |
| SD319.006 | In distribution | |
| 319.702 | In distribution | |
| 357.591 | In distribution | |
| 324.037 | In distribution | |
| 03.535.060 | In distribution | |
| 319.01 | In distribution | |
| SD351.718 | In distribution | |
| 03.045.036 | In distribution | |
| 319.04 | In distribution | |
| 03.113.016 | In distribution | |
| 03.111.005 | In distribution | |
| 03.424.090 | In distribution | |
| 03.110.020 | In distribution | |
| 319.007 | In distribution | |
| 03.113.020 | In distribution | |
| SD319.008 | In distribution | |
| 03.503.085 | In distribution | |
| 03.133.080 | In distribution | |
| 319.02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acetabular Shell Gauge | Biomet Orthopedics | 57 |
| Arthrex® | Arthrex, Inc. | 34 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 33 |
| Gauge, Depth | AAP Implantate AG | 33 |
| Newclip Instruments | Newclip Technics SAS | 28 |
| Recap® Femoral Head Resurfacing | Biomet Orthopedics | 23 |
| Tecomet | Tecomet, Inc. | 23 |
| Apex Knee System | Omni Life Science, Inc. | 22 |
| Ring-LOC(R) Acetabular Trial | Biomet Orthopedics | 21 |
| Depth gauge | Jeil Medical Corporation | 19 |
| Dyna Locking Trochanteric Nail | CG MedTech Co., Ltd. | 19 |
| Vanguard® | Biomet Orthopedics | 19 |
Showing 12 of 614. All products under Gauge, Depth
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.