Rod, Fixation, Intramedullary and Accessories
Locking Screw, Partially Threaded
17manufacturers in China registered for this device type
28catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Stryker Trauma Gmbh, Germany |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 25 to 120 mm |
| Distribution end date | 2020-12-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1796-4030S | Length 30.0 mm | Withdrawn |
| 1796-4025S | Diameter: 4.0 Millimeter | Withdrawn |
| 1791-5110S | Length 110.0 mm | Withdrawn |
| 1791-5030S | Length 30.0 mm | Withdrawn |
| 1791-5095S | Diameter: 5.0 Millimeter | Withdrawn |
| 1796-4050S | Diameter: 4.0 Millimeter | Withdrawn |
| 1791-5045S | Length 45.0 mm | Withdrawn |
| 1796-4035S | Length 35.0 mm | Withdrawn |
| 1791-5060S | Length 60.0 mm | Withdrawn |
| 1791-5085S | Diameter: 5.0 Millimeter | Withdrawn |
| 1791-5105S | Length 105.0 mm | Withdrawn |
| 1791-5090S | Length 90.0 mm | Withdrawn |
| 1791-5080S | Length 80.0 mm | Withdrawn |
| 1796-4060S | Diameter: 4.0 Millimeter | Withdrawn |
| 1796-4045S | Diameter: 4.0 Millimeter | Withdrawn |
| 1791-5055S | Length 55.0 mm | Withdrawn |
| 1791-5050S | Length 50.0 mm | Withdrawn |
| 1796-4040S | Diameter: 4.0 Millimeter | Withdrawn |
| 1791-5115S | Length 115.0 mm | Withdrawn |
| 1791-5120S | Length 120.0 mm | Withdrawn |
| 1791-5035S | Diameter: 5.0 Millimeter | Withdrawn |
| 1791-5075S | Length 75.0 mm | Withdrawn |
| 1791-5070S | Length 70.0 mm | Withdrawn |
| 1791-5040S | Diameter: 5.0 Millimeter | Withdrawn |
| 1791-5025S | Diameter: 5.0 Millimeter | Withdrawn |
| 1791-5100S | Diameter: 5.0 Millimeter | Withdrawn |
| 1791-5065S | Diameter: 5.0 Millimeter | Withdrawn |
| 1796-4055S | Length 55.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200869 | 2020-07-22 |
| K193308 | 2020-02-23 |
| K191271 | 2019-06-11 |
| K180436 | 2018-06-06 |
| K172774 | 2018-01-12 |
| K131365 | 2013-10-10 |
| K123401 | 2013-01-23 |
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.