Screwdriver
2.0MM Stardrive Scrwdrvr Blade W/Sprg Hldg SLV SHRT/66MM MQC
18manufacturers in China registered for this device type
485catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (3), Guangdong (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 18. All 18 manufacturers in China registered for Screwdriver
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HXX |
| Device type | Screwdriver |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K082649 |
| Record published | 2024-10-09 |
| 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 |
| Distribution end date | 2026-06-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03.420.302 | In distribution | |
| 396.303 | In distribution | |
| 03.507.000 | In distribution | |
| 03.611.111 | In distribution | |
| 03.007.021 | In distribution | |
| 313.847 | In distribution | |
| 03.164.024 | In distribution | |
| 314.463 | In distribution | |
| 314.57 | In distribution | |
| 389.807 | In distribution | |
| 314.80 | In distribution | |
| SD313.252 | In distribution | |
| SD387.282 | In distribution | |
| 314.092 | In distribution | |
| 313.96.96 | In distribution | |
| 03.611.071 | In distribution | |
| 324.064 | In distribution | |
| 03.010.519 | In distribution | |
| SD314.67 | In distribution | |
| 311.005 | In distribution | |
| 03.505.205 | In distribution | |
| 03.010.518 | In distribution | |
| 03.019.020 | In distribution | |
| 03.900.044 | In distribution | |
| 313.94 | In distribution | |
| SD03.045.005 | In distribution | |
| SD03.133.174 | In distribution | |
| SD314.112 | In distribution | |
| 03.614.019 | In distribution | |
| U44-642-20 | In distribution | |
| SD03.614.052 | In distribution | |
| 03.511.004 | In distribution | |
| SD314.170 | In distribution | |
| 03.113.019 | In distribution | |
| SD03.045.001 | In distribution | |
| 314.676 | In distribution | |
| 03.010.473 | In distribution | |
| 03.620.100 | In distribution | |
| 313.932 | In distribution | |
| 03.045.008 | In distribution | |
| 313.843 | In distribution | |
| 314.696 | In distribution | |
| 352.311 | In distribution | |
| SD314.230 | In distribution | |
| 03.611.116 | In distribution | |
| 03.505.217 | In distribution | |
| 314.67.97 | In distribution | |
| 03.614.040 | In distribution | |
| 03.133.175 | In distribution | |
| SD314.29 | In distribution | |
| SD395.330 | In distribution | |
| 313.917 | In distribution | |
| 03.231.016 | In distribution | |
| 03.505.103 | In distribution | |
| 03.010.152 | In distribution | |
| 03.632.090 | In distribution | |
| 03.611.101 | In distribution | |
| 03.610.605 | In distribution | |
| 313.833 | In distribution | |
| SD314.570 | In distribution | |
| 03.100.106 | In distribution | |
| 03.611.136 | In distribution | |
| 03.045.004 | In distribution | |
| 03.114.009 | In distribution | |
| 03.505.207 | In distribution | |
| 03.611.133 | In distribution | |
| 03.010.445 | In distribution | |
| 313.94.96 | In distribution | |
| 314.152 | In distribution | |
| 314.17 | In distribution | |
| 03.231.017 | In distribution | |
| SD388.338 | In distribution | |
| 314.44 | In distribution | |
| 03.632.055 | In distribution | |
| 03.611.145 | In distribution | |
| SD388.403 | In distribution | |
| 03.110.022 | In distribution | |
| 314.675 | In distribution | |
| 314.491 | In distribution | |
| 03.226.004 | In distribution | |
| 03.420.300 | In distribution | |
| SD03.503.067 | In distribution | |
| 03.110.007 | In distribution | |
| 03.614.050 | In distribution | |
| 313.827 | In distribution | |
| 314.14 | In distribution | |
| 03.505.005 | In distribution | |
| 03.632.098 | In distribution | |
| 03.535.302 | In distribution | |
| 314.02 | In distribution | |
| 393.745 | In distribution | |
| SD03.164.024 | In distribution | |
| 314.56 | In distribution | |
| 03.120.029 | In distribution | |
| 314.13 | In distribution | |
| 313.95 | In distribution | |
| 314.119 | In distribution | |
| SD314.115 | In distribution | |
| 314.118 | In distribution | |
| 03.111.038 | In distribution | |
| 03.900.042 | In distribution | |
| 314.16 | In distribution | |
| 314.75 | In distribution | |
| 03.119.027 | In distribution | |
| 03.207.006 | In distribution | |
| 03.620.001 | In distribution | |
| 03.620.064 | In distribution | |
| 03.010.092 | In distribution | |
| 314.68 | In distribution | |
| SD03.802.031 | In distribution | |
| SD314.675 | In distribution | |
| 03.045.014 | In distribution | |
| 314.451 | In distribution | |
| 03.611.124 | In distribution | |
| SD314.030 | In distribution | |
| 03.611.083 | In distribution | |
| 314.114 | In distribution | |
| SD314.029 | In distribution | |
| 387.285 | In distribution | |
| 03.119.019 | In distribution | |
| 314.693 | In distribution | |
| 03.010.472 | In distribution | |
| 313.99 | In distribution | |
| 03.611.072 | In distribution | |
| SD387.283 | In distribution | |
| 03.315.701 | In distribution | |
| 388.392 | In distribution | |
| SD03.632.076 | In distribution | |
| 03.505.210 | In distribution | |
| 03.611.081 | In distribution | |
| SD389.482 | In distribution | |
| SD395.331 | In distribution | |
| 03.119.006 | In distribution | |
| SD314.023 | In distribution | |
| 03.809.857 | In distribution | |
| 313.939 | In distribution | |
| 03.010.110 | In distribution | |
| 03.010.111 | In distribution | |
| 03.611.059 | In distribution | |
| 309.501 | In distribution | |
| SD314.696 | In distribution | |
| 313.97.96 | In distribution | |
| 314.671 | In distribution | |
| 313.97 | In distribution | |
| 311.007 | In distribution | |
| 03.621.012 | In distribution | |
| 03.226.041 | In distribution | |
| 03.614.039 | In distribution | |
| 314.00 | In distribution | |
| 03.611.103 | In distribution | |
| SD03.226.004 | In distribution | |
| 313.931 | In distribution | |
| 324.105 | In distribution | |
| 313.969 | In distribution | |
| SD388.153 | In distribution | |
| 03.505.215 | In distribution | |
| 03.010.121 | In distribution | |
| 03.010.411 | In distribution | |
| 03.611.134 | In distribution | |
| 03.505.221 | In distribution | |
| 03.114.002 | In distribution | |
| 388.38 | In distribution | |
| 313.838 | In distribution | |
| SD514.010 | In distribution | |
| 03.100.045 | In distribution | |
| 314.20 | In distribution | |
| 314.25 | In distribution | |
| 313.848 | In distribution | |
| 03.227.041 | In distribution | |
| 314.05 | In distribution | |
| 03.627.017 | In distribution | |
| 314.163 | In distribution | |
| 03.505.203 | In distribution | |
| 03.614.020 | In distribution | |
| 03.111.001 | In distribution | |
| 314.116 | In distribution | |
| 314.29 | In distribution | |
| 314.461 | In distribution | |
| 313.943 | In distribution | |
| 03.620.005 | In distribution | |
| 314.686 | In distribution | |
| 359.222 | In distribution | |
| 03.045.033 | In distribution | |
| 388.163 | In distribution | |
| 03.641.016 | In distribution | |
| 314.070 | In distribution | |
| 388.31 | In distribution | |
| 03.641.015 | In distribution | |
| 03.010.108 | In distribution | |
| 03.611.138 | In distribution | |
| 314.682 | In distribution | |
| 324.050 | In distribution | |
| 03.611.082 | In distribution | |
| SD03.164.028 | In distribution | |
| SD03.503.072 | In distribution | |
| 03.168.014 | In distribution | |
| 03.043.027 | In distribution | |
| 03.611.115 | In distribution | |
| 03.010.515 | In distribution | |
| 03.119.023 | In distribution | |
| SD388.032 | In distribution | |
| 03.611.121 | In distribution | |
| 03.611.112 | In distribution | |
| 313.922 | In distribution | |
| 03.611.142 | In distribution | |
| 314.67.96 | In distribution | |
| 314.411 | In distribution | |
| 311.014 | In distribution | |
| 03.505.101 | In distribution | |
| 388.079 | In distribution | |
| 03.611.114 | In distribution | |
| 03.505.211 | In distribution | |
| SD03.503.066 | In distribution | |
| 03.130.010 | In distribution | |
| 314.482 | In distribution | |
| 03.611.092 | In distribution | |
| SD314.123 | In distribution | |
| 03.611.076 | In distribution | |
| SD391.011 | In distribution | |
| 314.40 | In distribution | |
| 03.231.013 | In distribution | |
| 03.611.104 | In distribution | |
| 03.505.218 | In distribution | |
| 314.31 | In distribution | |
| 314.164 | In distribution | |
| 03.164.027 | In distribution | |
| 03.140.023 | In distribution | |
| 03.010.517 | In distribution | |
| 313.991 | In distribution | |
| SD314.118 | In distribution | |
| 314.038 | In distribution | |
| 03.114.010 | In distribution | |
| 03.620.022 | In distribution | |
| 311.016 | In distribution | |
| 03.611.123 | In distribution | |
| 314.431 | In distribution | |
| SD03.820.101 | In distribution | |
| 03.611.080 | In distribution | |
| SD314.040 | In distribution | |
| 314.03 | In distribution | |
| 389.224 | In distribution | |
| 03.505.216 | In distribution | |
| 313.822 | In distribution | |
| SD388.337 | In distribution | |
| 321.133 | In distribution | |
| 03.505.212 | In distribution | |
| SD314.113 | In distribution | |
| 03.100.105 | In distribution | |
| SD03.503.083 | In distribution | |
| 314.425 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tecomet | Tecomet, Inc. | 939 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 371 |
| Screwdriver | Medtronic Sofamor Danek, Inc. | 197 |
| Level ONE | KLS-Martin L.P. | 153 |
| Surgical Instrument | Jeil Medical Corporation | 116 |
| Invictus | Alphatec Spine, Inc. | 115 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 110 |
| Bradshaw Medical Inc. | Bradshaw Medical Inc. | 109 |
| Screwdriver | Depuy Spine, Inc. | 99 |
| Generic Surgical Instruments | CTL Medical Corporation | 93 |
| Surgical Direct | Surgical Direct, Inc. | 85 |
| General Instruments | Alphatec Spine, Inc. | 80 |
Showing 12 of 1,263. All products under Screwdriver
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | UDI-DI | 2024-04-25 | Class II | Process change control | Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay | 261 units |
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.